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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MERLIN PROGRAMMER; PROGRAMMER, PACEMAKER
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ABBOTT MERLIN PROGRAMMER; PROGRAMMER, PACEMAKER Back to Search Results
Model Number 3650
Device Problems Device Emits Odor (1425); Unintended Electrical Shock (4018)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/12/2021
Event Type  malfunction  
Event Description
It was reported that the power cord that connected into the merlin programmer was loose and unstable in its connection, and small electrical shocks were noted when it was plugged in and out of the port on the programmer.A burning odor was also reported.No patient or was involved and the user did not experience any adverse events due to the reported electrical shocks.
 
Manufacturer Narrative
The complaint that a power plug was unstable and smelled burned was not verified as the event could be not reproduced.The unit was plugged in to an external power source and powered on; the system booted up normally.There was no evidence of burning of charring.The reported event was unable to be confirmed.
 
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Brand Name
MERLIN PROGRAMMER
Type of Device
PROGRAMMER, PACEMAKER
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
MDR Report Key11685310
MDR Text Key246009331
Report Number2017865-2021-15003
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734500661
UDI-Public05414734500661
Combination Product (y/n)N
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3650
Device Catalogue Number3650
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2021
Was the Report Sent to FDA? No
Date Manufacturer Received06/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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