MAUDE Adverse Event Report: MEDTRONIC INC. CARELINK; PROGRAMMER, PACEMAKER

Model Number 2090

Device Problems Nonstandard Device (1420); Delamination (2904)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that the radiofrequency programmer head originally returned with no information was subsequently found during manufacturer¿s analysis to have its device label delaminated.It was further reported that the programmer originally returned with no information subsequently tested out of specification during manufacturer¿s analysis.There was no patient involvement.

Manufacturer Narrative

This report is based solely on device analysis.No information to suggest a device related adverse event or product problem was received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: during analysis it was determined that the stylus was damaged, the keyboard was broken, the power cord bay was broken and there was a cracked cover handle, all were replaced and the stylus calibrated.(b)(4).

• Brand Name: CARELINK
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MEDTRONIC INC.; 8200 coral sea st ne; mounds view,mn 5511 2
• 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: 4313270
• MDR Text Key: 5132149
• Report Number: 2182208-2014-03468
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/23/2014

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: Other
• Device Model Number: 2090
• Device Catalogue Number: 2090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: 2067 RADIOFREQUENCY PROGRAMMER HEAD