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

Model Number 5487

Device Problems Failure to Capture (1081); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/10/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the cables would not capture when connected to the leads and to an external pulse generator (epg).The physician then opted to connect the leads to an implantable pulse generator (ipg) that was taped externally to the patient's neck until a device could be implanted.The cables are expected to be returned for service.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product analysis: manufacturer's analysis was unable to confirm the customer comment that the cable would not capture.The cable passed incoming visual inspection with no anomalies found.The cable passed all continuity tests.There were no intermittent or shorted connections found.If information is provided in the future, a supplemental report will be issued.

Event Description

The cables were returned for analysis.

• 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: 8624881
• MDR Text Key: 145538194
• Report Number: 2182208-2019-00934
• Device Sequence Number: 1
• Product Code: DSA
• UDI-Device Identifier: 00643169307353
• UDI-Public: 00643169307353
• 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
• Report Date: 06/04/2019

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: 675820001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 05/20/2019
• Supplement Dates Manufacturer Received: 05/23/2019
• Supplement Dates FDA Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2018
• 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
• Treatment: 5076 LEAD, EXTERNAL PULSE GENERATOR
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR