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

Model Number 5833SL

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

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

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the complaint was confirmed; positive connection continuity tests on the cable measured open.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that device testing was unable to be performed using this cable.A different cable was able to be used with no issue.The cable was returned.No patient complications have been reported as a result of this event.

• Brand Name: NA
• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7516706
• MDR Text Key: 108358233
• Report Number: 2182208-2018-00913
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00681490136365
• UDI-Public: 00681490136365
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• 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: 663970001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2018
• 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
• Patient Age: 71 YR