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

Model Number 5487

Device Problems Capturing Problem (2891); Material Integrity Problem (2978)

Patient Problem Cardiac Arrest (1762)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10552689
• MDR Text Key: 207499838
• Report Number: 2182208-2020-01931
• Device Sequence Number: 1
• Product Code: DSA
• UDI-Device Identifier: 00643169307339
• UDI-Public: 00643169307339
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/18/2020
• Date Device Manufactured: 06/29/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 62 YR