MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. MERLIN PROGRAMMER; PACEMAKER PROGRAMMER

Model Number 3650

Device Problem Incorrect Software Programming Calculations (1495)

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

Event Date 10/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

During follow-up the device was at eri.The longevity estimate provided by the programmer at previous follow-up overestimated the device longevity.The device was replaced and the patient is in good condition.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: MERLIN PROGRAMMER
• Type of Device: PACEMAKER PROGRAMMER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6198726
• MDR Text Key: 63488528
• Report Number: 2017865-2016-07979
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1