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

Model Number 3650

Device Problem No Pacing (3268)

Patient Problem Dizziness (2194)

Event Date 12/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

While performing the ventricular capture test, the programmer failed the test and the patient was without pacing for a few seconds.The emergency vvi button needed to be pressed to pace the patient.The patient experienced dizziness during the episode.The programmer was restarted, and the test was completed.The patient was in stable condition.

Manufacturer Narrative

Tried several attempts with the vvi button functionality.Unable to reproduce any functionality problem of the vvi button.

• 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: 6262423
• MDR Text Key: 65512349
• Report Number: 2017865-2017-00422
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention