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

Model Number 2090

Device Problems Failure to Power Up (1476); Sparking (2595); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 06/22/2016

Event Type  malfunction  

Manufacturer Narrative

Product event summary: it was confirmed that the programmer would not turn on, and there were popping and clicking sounds when attempting to power on.The programmer was found to have a faulty power supply and a loose power supply switch.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the programmer would not turn on.When an attempt was made to power on, there were sparks in the area of where the power cord plugs in, and an electrical popping and clicking sound could be heard.The programmer has been returned to service.There was no patient involvement.

• 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, 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: 5863664
• MDR Text Key: 51832926
• Report Number: 2182208-2016-02142
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P890003
• 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
• Report Date: 06/22/2016

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: Other
• Device Model Number: 2090
• Device Catalogue Number: 2090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2003
• 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