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

Model Number EX1150

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

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

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the patient's transmitter had no power and exhibited a burning smell coming from the power adaptor.The transmitter was replaced.No patient consequences were reported.

Manufacturer Narrative

Final analysis found a defective ac power adapter which resulted in power up anomaly.

• Brand Name: MERLIN@HOME, RF TELEMETRY BASIC
• 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: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7443948
• MDR Text Key: 105960741
• Report Number: 2017865-2018-05975
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EX1150
• Device Catalogue Number: EX1150
• Other Device ID Number: 05414734504799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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: 84 YR