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

Model Number EX1100

Device Problem Charred (1086)

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

Event Date 08/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a lightening storm had occurred and the patient's transmitter is burnt.The transmitter was replaced.

• 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: jaime chavez ; 15900 valley view court; sylmar, CA 91342 ; 8184934022
• MDR Report Key: 5991759
• MDR Text Key: 56349217
• Report Number: 2017865-2016-06321
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EX1100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2012
• 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 Age: 89 YR