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

Model Number 2090

Device Problem Mechanical Problem (1384)

Patient Problems Cardiac Arrest (1762); Injury (2348)

Event Date 04/16/2020

Event Type  Injury  

Manufacturer Narrative

Product analysis: it was also determined at analysis that the programmer suddenly displayed a warning message ¿programmer overheating please turn the programmer off¿, this was due to a worn power supply.All found defective parts were replaced and all other identified issues were resolved.The device then passed all final functional tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the patient is pacemaker dependent, during the procedure whilst using the analysers surgical cable, transmission was lost between the analyser and the implanted electrode.There was a sudden loss of stimulation, no peaks were visible on the monitor, connection and the lead position was checked, cardiac massage during asystole was required.After change to another programmer and another measuring cable regular stimulation took place again.The procedure was completed using a different device.It was further reported the programmer was used the following day with no issues reported.Hospitalisation and intervention was required as a result of this event.The programmer will be returned for service to be tested with the cable.Injury reported.

• Brand Name: CARELINK 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: 10337140
• MDR Text Key: 200760984
• Report Number: 2182208-2020-01380
• Device Sequence Number: 1
• Product Code: KRG
• 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,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/29/2020

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: 05/11/2020
• Initial Date Manufacturer Received: 07/03/2020
• Initial Date FDA Received: 07/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2011
• 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: 2067L RF HEAD, 2292 ANALYZER, SURGICAL CABLE
• Patient Outcome(s): Hospitalization; Required Intervention