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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 PROGRAMMER
Device Problem Incorrect Measurement (1383)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2022
Event Type  malfunction  
Event Description
It was reported that the remaining battery longevity was overestimated.The programmer software version was unknown at the most recent check.The device was explanted and replaced prior to reaching elective replacement indicator (eri) voltage level.The patient was in stable condition.
 
Manufacturer Narrative
Further information was requested but not received.
 
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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 Key17360713
MDR Text Key319407309
Report Number2017865-2023-36263
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 07/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPROGRAMMER
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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