MAUDE Adverse Event Report: MEDTRONIC ZONE IND. SUD FRANCE S.A.; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 6416-200

Device Problem Fracture (1260)

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

Event Date 12/06/2015

Event Type  malfunction  

Manufacturer Narrative

Product event summary:the full lead was returned and analyzed.The proximal conductor of the lead developed a fracture due to flexing while in vivo.

Event Description

It was reported that the lead was returned after being used for gastric pacing.The physician was happy with the lead and requested analysis for lead integrity after use in the gastric environment.The lead was returned and tested out of specification.No 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.

• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): MEDTRONIC ZONE IND. SUD FRANCE S.A.; route d'anor 59610, fourmies,; fourmies 59610 ; FR 59610
• Manufacturer (Section G): MEDTRONIC ZONE IND. SUD FRANCE S.A.; route d'anor 59610, fourmies,; fourmies 59610 ; FR 59610
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5861317
• MDR Text Key: 51862497
• Report Number: 6000022-2016-00002
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2016
• Device Model Number: 6416-200
• Device Catalogue Number: 6416-200
• Device Lot Number: AHH113209F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1