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

Model Number	2067L
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: it was found that, when the rf head was connected to a known working programmer, it would cause the programmer to power off.The rf head was forwarded for repair.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The radio frequency (rf) programmer head was returned for inspection, and subsequently tested out of specification.There was no patient involvement.
Additional Manufacturer Narrative
Product analysis:additional analysis confirmed that when the radiofrequency (rf) head was plugged into a programmer, the programmer would power down.The rf head failed 30 out of 44 functional tests.The rf head cable was replaced.The rf upper case was replaced due to a cracked lens.All found defective parts were replaced and all other identified issues were resolved.The device then passed all final functional tests.If information is provided in the future, a supplemental report will be issued.

• 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: 8074715
• Report Number: 2182208-2018-02084
• Device Sequence Number: 11185889
• Product Code: KRG
• UDI-Device Identifier: 00721902290138
• UDI-Public: 00721902290138
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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: Other
• Device Model Number: 2067L
• Device Catalogue Number: 2067L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1