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

Model Number 2290

Device Problems Under-Sensing (1661); Device Sensing Problem (2917)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2016

Event Type  Injury  

Manufacturer Narrative

Product event summary: it could not be confirmed that sensing from the analyzer was variable, it passed all functional and systems tests.It was found that the analyzer's patient connector had disturbed pins.

Event Description

It was reported that during an implant procedure, sensing from the analyzer was variable.The lead, cable, and adapters on the programmer were changed without effect.The programmer was exchanged, and there were much better values when using a new programmer and analyzer.It was noted that the analyzer appeared to have been reporting r waves below their actual value.The right ventricular (rv) lead remains in use, although it was repositioned multiple times.The analyzer has been returned to 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: 6005149
• MDR Text Key: 56765452
• Report Number: 2182208-2016-02251
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2290
• Device Catalogue Number: 2290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2003
• 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): Other; Required Intervention