MAUDE Adverse Event Report: MEDTRONIC, INC. PATIENT CABLE; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 5833SL

Device Problems Impedance Problem (2950); Output Problem (3005)

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

Event Date 09/12/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was electrogram (egm) noise and high impedance during measurement.Multiple attempts were made to hook and unhook the disposable surgical cables to resolve the issue.When the cables were replaced with different cables of the same model, the issue was resolved.The cables are expected to be returned.No patient complications have been reported as a result of this event.It was further reported that the cable was returned for analysis.

Manufacturer Narrative

Product analysis: analysis was unable to confirm the reported issue.The cable passes all incoming tests and no anomalies were noted.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PATIENT CABLE
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• 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: 9163227
• MDR Text Key: 162637632
• Report Number: 2182208-2019-01795
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5833SL
• Device Catalogue Number: 5833SL
• Device Lot Number: 709730001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Date Manufacturer Received: 10/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2019
• 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