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

Model Number 3650

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Electric Shock (2554); No Known Impact Or Consequence To Patient (2692)

Event Date 11/10/2017

Event Type  malfunction  

Event Description

During device preparation, while pushing the start button, the programmer gave the user an electric shock and then would not power on.This happened twice to different users.The user's were stable with no adverse consequences.Related manufacturer report number: 2017865-2017-35232.

Manufacturer Narrative

The programmer was returned for analysis.Visual inspection revealed no physical damage to the unit.During analysis, the programmer was unable to advance past the startup page.The root cause of the start-up anomaly was identified as a defective power switch.However, no root cause was determined for the electric shock to the user in the field.

• 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: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7076710
• MDR Text Key: 93634141
• Report Number: 2017865-2017-35302
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: No
• 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: 12/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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