MAUDE Adverse Event Report: MEDTRONIC, INC.; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

Model Number 5388

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 09/04/2014

Event Type  malfunction  

Event Description

It was reported that the lower display is cracked and not showing on right side.The external pulse generator (epg) has been returned for repair.There was no patient involvement.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: analysis confirmed the reported event, the display was missing segments on the right side.It was also noted that the lower case was damaged, the side cover bails and side bails were missing, the lead flex cover was contaminated and the ring was bent.(b)(4).

• Type of Device: PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4313445
• MDR Text Key: 5209716
• Report Number: 2182208-2014-03445
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P820003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5388
• Device Catalogue Number: 5388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2012
• 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