MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) MERLIN PROGRAMMER; PACEMAKER PROGRAMMER

Model Number 3650

Device Problem Telemetry Discrepancy (1629)

Patient Problems Dizziness (2194); Loss Of Pulse (2562)

Event Date 10/10/2017

Event Type  Injury  

Event Description

It was reported that a pacer dependent patient presented in-clinic for follow-up.While running a decrement threshold test, the "cancel test" was greyed out longer than expected.For a few beats, the patient was asystolic and became very lightheaded.Telemetry discrepancy with the merlin programmer was suspected.The patient would continue to be monitored.

Manufacturer Narrative

The field complaint of pacing drop-outs could not be verified.The programmer was used to interrogate and several tests were run on an in-house implantable cardioverter defibrillator.When the test was canceled, there would be a 2-4 second delay from the time the test was cancelled till the time the pacer would return to its programmed values, but at no time did pacing dropped out.

• Brand Name: MERLIN PROGRAMMER
• Type of Device: PACEMAKER PROGRAMMER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7015125
• MDR Text Key: 91525568
• Report Number: 2017865-2017-34363
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3650
• Other Device ID Number: 05414734500661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2008
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR