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

Model Number	2067
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: analysis found the rf (radio frequency) head cable had a short circuit; programmer wouldn't power up due to the shorted rf head cable.Analysis also found the plastic anti-slip layer was ripped off the label of the programming head.It was noted the rf head upper case was worn.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 or Problem Description
It was reported when the programmer was turned on nothing happened, black screen.The rf (radio frequency) head was returned to the manufacturer, analyzed and tested out of specification.There was no patient involvement.

• Brand Name: CARELINK
• Common Device Name: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 6625919
• Report Number: 2182208-2017-00836
• Device Sequence Number: 662279
• Product Code: KRG
• UDI-Device Identifier: 00721902290121
• UDI-Public: 00721902290121
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P890003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2067
• Device Catalogue Number: 2067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2017
• Initial Report FDA Received Date: 06/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1