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

Model Number 2090

Device Problems Device Difficult to Program or Calibrate (1496); Communication or Transmission Problem (2896)

Patient Problem Shock (2072)

Event Date 02/14/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during the lead revision procedure, telemetry to the device would cut in and out intermittently.Therapies on the device were programmed off, but telemetry cut out again, and the programming changes were not transmitted to the device.The patient received an inappropriate shock when cautery was used during the procedure.The programmer has been returned.No further patient complications have been reported.

Manufacturer Narrative

Product analysis: analysis confirmed the reported issues; the link electronic module (lem) printed circuit board (pcb) failed incoming testing and was electrically out of specification.It was also found that the power cord bay and keyboard latch assemblies were broken.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.

• 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: 7413892
• MDR Text Key: 104927035
• Report Number: 2182208-2018-00394
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00613994175397
• UDI-Public: 00613994175397
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• 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: 04/05/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2002
• 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: 6936-65 LEAD, 6933-35 LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 69 YR