MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) MERLIN@HOME INDUCTIVE VERSION; PACEMAKER DATA TRANSMITTER

Model Number EX1100

Device Problems Device Emits Odor (1425); Failure to Power Up (1476)

Patient Problem Shock (2072)

Event Date 06/14/2017

Event Type  Injury  

Event Description

It was reported that the patient got shocked while plugging in the transmitter; the device also emitted a burning odor.The device did not start, the lights were not on.No additional information was reported.

Manufacturer Narrative

This supplemental report is to correct the previously reported information.The patient was okay during the event.

Event Description

The patient was okay during the event.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• Brand Name: MERLIN@HOME INDUCTIVE VERSION
• Type of Device: PACEMAKER DATA TRANSMITTER
• 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: 6704251
• MDR Text Key: 79725424
• Report Number: 2017865-2017-05430
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EX1100
• Other Device ID Number: 05414734504782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2013
• 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 Age: 67 YR