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

Model Number 2067

Device Problems Delamination (2904); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 07/31/2014

Event Type  malfunction  

Event Description

It was reported that the radiofrequency programmer head originally returned as an associated device was subsequently found during manufacturer¿s analysis to have its label missing the back coating, its cable insulation torn and its lens cracked on the upper case.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 label was missing its back coating, its cable insulation was torn and its lens on the upper case was cracked.All were replaced.(b)(4).

• Brand Name: CARELINK
• Type of Device: PROGRAMMER, PACEMAKER
• 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: 4312074
• MDR Text Key: 5251112
• Report Number: 2182208-2014-03343
• 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: 09/15/2014

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: 2067
• Device Catalogue Number: 2067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2004
• 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: 2090 PROGRAMMER