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

Model Number 3650

Device Problems Device Emits Odor (1425); Loss of Power (1475); Computer Operating System Problem (2898)

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

Event Date 01/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Final analysis found a defective power supply.(b)(4).

Event Description

It was reported that the programmer suddenly shut down during follow up in clinic.The clinician could smell burning.The programmer could not be rebooted.

• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6368189
• MDR Text Key: 68995242
• Report Number: 2017865-2017-01313
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 02/07/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2017
• Initial Date FDA Received: 03/01/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1