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

Model Number 2090

Device Problem Computer Operating System Problem (2898)

Patient Problem Ventricular Fibrillation (2130)

Event Date 06/09/2015

Event Type  Injury  

Event Description

It was reported that a vector express test was started and the patient spontaneously went into ventricular fibrillation.It was then impossible to manually deliver the shock because the programmer was non-responsive.A window popped up during the test and it could not be completed due to the competing rhythm.The programmer had to be shut down and restarted twice.The associated implantable cardioverter defibrillator (icd) was not programmed on because the implant procedure was not yet over.The patient did not receive any high voltage therapies from the icd.Before and after this incident, no issues with the touch pen.This was a new programmer, only used once or twice prior to this event.External defibrillation was needed since the internal icd was off and the programmer was frozen, so it was not possible to turn on therapies.The programmer is expected to be returned to the manufacturer.No further complications were reported as a result of this event.

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).

Manufacturer Narrative

Product event summary: analysis could not confirm the reported event, however a new software installation was performed to solve the problem.

• 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 CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4970255
• MDR Text Key: 6327522
• Report Number: 2182208-2015-02465
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 07/24/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2015
• Initial Date FDA Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2013
• 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
• Patient Outcome(s): Life Threatening; Required Intervention