MAUDE Adverse Event Report: MEDTRONIC, INC. ADAPTOR CABLE; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

Model Number	5103
Medical Device Problem Codes	No Device Output (1435); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	07/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the adapter cable had a bent pin and was unable to properly connect to the mobile programmer base.It was noted that the pacing from the analyser was not possible when the patient was in asystole.It was further noted that external pacing was required and the lead was attached to a generator to provide emergency pacing.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: analysis was able to confirm the customer comment that the adapter cable had a bent pin.Ventricular negative (pin 24) was bent and not making contact.The cable passed all other visual inspection.All other continuity tests were ok.No intermittent or shorted connections were found.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Correction fdc code h6.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ADAPTOR CABLE
• Common Device Name: PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635269277
• MDR Report Key: 19826417
• Report Number: 2182208-2024-03002
• Device Sequence Number: 8728373
• Product Code: DXY
• UDI-Device Identifier: 00643169838604
• UDI-Public: 00643169838604
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P890003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5103
• Device Catalogue Number: 5103
• Device Lot Number: 731380001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female