MAUDE Adverse Event Report: MEDTRONIC INC PACING SYSTEM ANALYZER; PROGRAMMER, PACEMAKER

Model Number 229047

Device Problem Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis found that the analyzer was out of specification electrically as it failed functional tests.The device was mechanically intact.The analyzer was removed.If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that the analyzer subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.

• Brand Name: PACING SYSTEM ANALYZER
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MEDTRONIC INC; 8200 coral sea st ne; moundsview MN 55112
• Manufacturer (Section G): MEDTRONIC INC; 8200 coral sea st ne; moundsview MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10591984
• MDR Text Key: 208711517
• Report Number: 2182208-2020-02082
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00721902256011
• UDI-Public: 00721902256011
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/28/2020

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
• Device Operator: Other
• Device Model Number: 229047
• Device Catalogue Number: 229047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 09/28/2020
• 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
• Treatment: 2090 PROGRAMMER