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

Model Number 229047

Device Problem Failure to Capture (1081)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Type  Injury  

Manufacturer Narrative

Product event summary: at analysis the device was noted to be mechanically intact and passed all incoming functional tests.The battery voltage was low (depleted) though this was additionally noted to be normal.The battery was replaced and the device passed functional and systems tests.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the software analyzer experienced a loss of capture.It was further reported via follow-up that this occurred while threshold tests were being performed during an implant.The analyzer was changed out for another and the procedure was completed however it was noted that the patient experienced some pauses but no long-term consequences.The analyzer was returned for service.No further patient complications have been reported as a result of this event.

• 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: 6318382
• MDR Text Key: 67084946
• Report Number: 2182208-2017-00189
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 229047
• Device Catalogue Number: 229047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2016
• Date Manufacturer Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2005
• 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