MAUDE Adverse Event Report: MEDTRONIC, INC. PATIENT CABLE; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Model Number	5487
Medical Device Problem Codes	Capturing Problem (2891); Material Integrity Problem (2978)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	08/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during a revision procedure, two days after a patient was given a temporary external pacer, the cables did not work as pacing from the external temporary pacer did not occur.It was noted that whilst testing the lead with alligator clip cables to a programmer, the impedance and threshold readings were normal however when connecting these cables, the patient experienced asystole.The external temporary pacer was at max output at 100 beats per minute (bpm) although there was no capture.The cable was changed out for an alternative cable from the same lot which gave the same result.A different external temporary pacer with a second set of wires was used and still showed no capture.In the event the lead that was previously implanted was used to continue to pace the unit until the clinician was ready to implant on the other side.The cables have been discarded.No further patient complications have been reported as a result of this event.

• Brand Name: PATIENT CABLE
• Common Device Name: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 10552689
• Report Number: 2182208-2020-01931
• Device Sequence Number: 14239469
• Product Code: DSA
• UDI-Device Identifier: 00643169307339
• UDI-Public: 00643169307339
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K960446
• 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
• Report Date (Section B): 09/18/2020

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 Expiration Date: 06/17/2022
• Device Model Number: 5487
• Device Catalogue Number: 5487
• Device Lot Number: 779420001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 62 YR