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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Patient Involvement (2645)
Event Date 10/12/2017
Event Type  malfunction  
Manufacturer Narrative
No complaint was received with return of the device; failure event observed during analysis.Final analysis found burn marks on the circuit board/printed circuit board (pcb) and ac power adapter which resulted in power up anomaly.
 
Event Description
This report is to advise of an event observed during analysis.
 
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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 Key6995284
MDR Text Key91081635
Report Number2017865-2017-33788
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 other
Type of Report Initial
Report Date 11/01/2017
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 Other
Device Model NumberEX1150
Other Device ID Number05414734504799
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/29/2017
Initial Date Manufacturer Received 10/12/2017
Initial Date FDA Received11/01/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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