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

Model Number 2090

Device Problems Telemetry Discrepancy (1629); Communication or Transmission Problem (2896); Output below Specifications (3004)

Patient Problem No Patient Involvement (2645)

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis found that the programmer could not interrogate, the radiofrequency head connector on the link electronic module (lem) board was out of specification.It was also found that the programmer's stylus did not work at all.All found defective parts were replaced and all other identified issues were resolved.The device was re-calibrated and functionally tested.The device passed all final testing.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the telemetry of the programmer was not working correctly.The radiofrequency head was changed but the problem was not resolved.The programmer was returned for service.There was no patient involvement.The programmer subsequently tested out of specification during manufacturer's analysis.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: CARELINK
• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7747753
• MDR Text Key: 116240129
• Report Number: 2182208-2018-01417
• Device Sequence Number: 0
• Product Code: KRG
• Reporter Country Code: SP
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2090
• Device Catalogue Number: 2090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2007
• 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