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

Model Number 5487

Device Problems Failure to Capture (1081); Over-Sensing (1438); Connection Problem (2900); Material Integrity Problem (2978)

Patient Problem Cardiac Arrest (1762)

Event Date 07/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event 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.

Manufacturer Narrative

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

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
• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7756658
• MDR Text Key: 116232657
• Report Number: 2182208-2018-01431
• Device Sequence Number: 1
• Product Code: DSA
• UDI-Device Identifier: 20643169307333
• UDI-Public: 20643169307333
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 08/07/2018
• Supplement Dates Manufacturer Received: 08/17/2018; 08/08/2018
• Supplement Dates FDA Received: 08/21/2018; 10/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 87 YR