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

Model Number EX1150

Device Problems Thermal Decomposition of Device (1071); Charred (1086)

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

Event Date 09/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the merlin.Net transmitter would not power after a storm.Power adaptor box exhibited charring on internal prongs.The device was exchanged.

Manufacturer Narrative

Final analysis found an integrated circuit board anomaly which resulted in power anomaly.

• Brand Name: MERLIN@HOME, RF TELEMETRY BASIC
• Type of Device: PACEMAKER DATA TRANSMITTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6087915
• MDR Text Key: 59561550
• Report Number: 2017865-2016-07058
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/08/2017

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: EX1150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/19/2016
• Initial Date FDA Received: 11/08/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 08/01/2017
• Supplement Dates FDA Received: 11/28/2016; 03/03/2017; 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2012
• 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