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

Model Number 29901A

Device Problems Computer Software Problem (1112); Device Difficult to Program or Calibrate (1496); Operating System Becomes Nonfunctional (2996)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2022

Event Type  malfunction  

Manufacturer Narrative

Analysis was unable to confirm the customer comment that the programmer crashed multiple times to a black screen.It was noted that the programmer stylus was not in alignment with the cursor.It was also noted that part of the display was separating and was moving when touched.The computer platform was replaced.The programmer hard drive was reconfigured and the programmer software was reloaded and updated.All found defective parts were replaced and all other identified issues were resolved.The instrument then 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 programmer crashed multiple times to a black screen with a diagnostic message outside of patient session.The programmer was returned to service and subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.

• Brand Name: CARELINK ENCORE PROGRAMMER
• 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: 15327462
• MDR Text Key: 305371887
• Report Number: 2182208-2022-02814
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00643169763548
• UDI-Public: 00643169763548
• 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: 08/31/2022

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: 29901A
• Device Catalogue Number: 29901A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2022
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2019
• 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