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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) MERLIN@HOME, RF TELEMETRY BASIC PACEMAKER DATA TRANSMITTER Back to Search Results
Model Number EX1150
Device Problem Power Conditioning Problem (1474)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/31/2017
Event Type  malfunction  
Manufacturer Narrative
Final analysis found burn marks on the printed circuit board which resulted in power up anomaly. It was suspected that the damage sustained occurred after exposure to an electrical storm.
 
Event Description
It was reported that the patient's home was hit by lightning and the merlin at home transmitter lost power. The device would no longer be used and replaced.
 
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Brand NameMERLIN@HOME, RF TELEMETRY BASIC
Type of DevicePACEMAKER 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 Key6942972
MDR Text Key89521158
Report Number2017865-2017-32881
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 10/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEX1150
Other Device ID Number05414734504799
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2017
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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