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

Model Number 5833

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 06/06/2017

Event Type  malfunction  

Event Description

It was reported that prior to use it was noted that the alligator clip was broken off the surgical cable.The cable is expected to be returned to service.There was no patient involvement.

• 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: 6920608
• MDR Text Key: 89489226
• Report Number: 2182208-2017-01536
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5833
• Device Catalogue Number: 5833
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/14/2017
• Initial Date FDA Received: 10/06/2017
• 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