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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (CRM-KISTA) MERLIN@HOME, RF TELEMETRY BASIC; PACEMAKER DATA TRANSMITTER
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ST. JUDE MEDICAL, INC. (CRM-KISTA) MERLIN@HOME, RF TELEMETRY BASIC; PACEMAKER DATA TRANSMITTER Back to Search Results
Model Number EX1150
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/05/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient presented remotely via merlin.Net when he smelled smoke.The patient unplugged the merlin device and when he plugged it back up, the device was no longer working.The device would no longer be used and replaced.
 
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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-KISTA)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC. (CRM-KISTA)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
ulla strindlund
box 7051
isafjordsgatan 15
kista SE-16-407
SW   SE-16407
4684744043
MDR Report Key5308556
MDR Text Key34274483
Report Number3010215456-2015-32761
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 11/09/2015
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 NumberEX1150
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/09/2015
Initial Date FDA Received12/17/2015
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age68 YR
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