<?xml version='1.0' encoding='UTF-8'?><device xmlns='http://www.fda.gov/cdrh/gudid' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'><publicDeviceRecordKey>1aa9e2f9-042c-4235-b550-6b6d0144a781</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2026-01-07</publicVersionDate><devicePublishDate>2025-11-16</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00763000913069</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>InterStim™
SureScan™</brandName><versionModelNumber>978A128</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>006261481</dunsNumber><companyName>MEDTRONIC, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>LEAD 978A128 ISTM 2.16MM EUMDR EMAN LI08</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>true</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>MR Conditional</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1(800)633-8766</phone><phoneExtension xsi:nil="true"/><email>Corporate.UDI@medtronic.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>P080025</submissionNumber><supplementNumber>223</supplementNumber></premarketSubmission><premarketSubmission><submissionNumber>P970004</submissionNumber><supplementNumber>328</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>44045</gmdnCode><gmdnPTName>Sacral plexus implantable incontinence-control electrical stimulation system electrode</gmdnPTName><gmdnPTDefinition>An implantable wire, insulated with non-conductive material except at its electrode(s), intended to be used to treat chronic disorders of the pelvis and lower urinary or intestinal tract, typically related to urinary and/or faecal incontinence. It is implanted on the sacral plexus or in its vicinity (e.g., anal sphincter, bladder wall, pelvic floor) to make an electrical connection between an implantable electrical stimulation system pulse generator and the sacral plexus area.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EZW</productCode><productCodeName>Stimulator, electrical, implantable, for incontinence</productCodeName></fdaProductCode><fdaProductCode><productCode>QON</productCode><productCodeName>Implanted electrical device intended for treatment of fecal incontinence</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Length</sizeType><size unit="Centimeter" value="28.0"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>