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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MERLIN PROGRAMMER; No Match
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ABBOTT MERLIN PROGRAMMER; No Match Back to Search Results
Model Number 3650
Device Problem Incorrect Measurement (1383)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/26/2022
Event Type  malfunction  
Manufacturer Narrative
Further information was requested but not received.
 
Event Description
It was reported that the remaining battery longevity was overestimated.The programmer software version was unknown at the most recent estimated remaining voltage measurement.The device was explanted and replaced prior to reaching elective replacement indicator (eri) voltage level.The patient was in stable condition.
 
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Brand Name
MERLIN PROGRAMMER
Type of Device
No Match
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer Contact
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key17436173
MDR Text Key320164367
Report Number2017865-2023-36157
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3650
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/12/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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