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

Model Number	2067L
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the programmer displayed a black screen when attempting to interrogate the pacemaker.The programmer was returned for service. it was further reported that the programmer radiofrequency head subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.
Additional Manufacturer Narrative
Product analysis: analysis was able to confirm the customer comment that programmer displayed a black screen when attempting to interrogate the pacemaker.It was also determined at analysis that the programmer's radiofrequency(rf) head cable short circuited, the shielding was damaged, and the inner cores were visible.The rf head was still working but will be replaced.It was also determined at analysis that the rf head anti-slip layer was ripped off.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: PROGRAMMING HEAD
• Common Device Name: 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 13042425
• Report Number: 2182208-2021-04977
• Device Sequence Number: 5424291
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2021

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: 09/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRGM 2090EN
• Patient Sex: Unknown