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

Model Number	5487
Medical Device Problem Codes	Over-Sensing (1438); Connection Problem (2900); Material Integrity Problem (2978)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	07/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that, while being paced with an external pulse generator (epg) during a device replacement procedure, the patient went into asystole, with loss of capture and oversensing exhibited.It was noted that the issue arose when the replacement lead and patient cable were being taped down.The patient was paced with an external defibrillator and the connection between the patient cable and lead was adjusted, but the issue persisted.The lead was connected to a pacing analyzer and shown to function normally.The patient cable was replaced, and the patient was able to be paced with the epg and lead without issue.It was noted that the implanting physician attributed the issue to the connector block of the patient cable.The cable was returned for analysis.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: the complaint could not be confirmed.The cable passed visual inspection and continuity tests with no connection issues identified.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NA
• 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: 7756658
• Report Number: 2182208-2018-01431
• Device Sequence Number: 16493736
• Product Code: DSA
• UDI-Device Identifier: 20643169307333
• UDI-Public: 20643169307333
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K960446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

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: 5487
• Device Catalogue Number: 5487
• Device Lot Number: 648490001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 08/17/2018; 08/08/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 08/21/2018; 10/02/2018
• 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: 87 YR