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

Model Number 2067L

Device Problem Electrical Shorting (2926)

Patient Problem No Patient Involvement (2645)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis noted that the radiofrequency (rf) head cable was damaged and was shorting, causing the associated programmer to shutdown during the start up process.The rf head cable was replaced.The device passed all final functional tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the radiofrequency programmer head originally returned as an associated device subsequently tested out of specification during manufacturer¿s analysis.There was no patient involvement.

• Brand Name: PROGRAMMING HEAD
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9187695
• MDR Text Key: 162641876
• Report Number: 2182208-2019-01834
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00721902290138
• UDI-Public: 00721902290138
• 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,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/14/2019

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
• Device Operator: Other
• Device Model Number: 2067L
• Device Catalogue Number: 2067L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 10/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2008
• 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