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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT PROMOTE PLUS CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ABBOTT PROMOTE PLUS CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3211-36
Medical Device Problem Codes Premature Discharge of Battery (1057); Failure to Interrogate (1332)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/26/2021
Type of Reportable Event Serious Injury
Event or Problem Description
During a follow-up, the device could not be interrogated due to being at end of life (eol).Premature battery depletion was alleged.The device was explanted and replaced, and the patient was stable with no consequences.
 
Additional Manufacturer Narrative
The reported field event of communication failure was confirmed by analysis, but premature battery depletion could not be confirmed.A longevity calculation was performed using default settings and showed that the battery depletion was normal.Furthermore, no sources of high current were noted.The device's functionality was bench tested, including telemetry, pacing, sensing, impedance, high voltage output, high voltage shock, and patient notifier and no anomalies were detected.
 
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Brand Name
PROMOTE PLUS CRT-D
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
MDR Report Key11624570
Report Number2017865-2021-13278
Device Sequence Number3668229
Product Code NIK
UDI-Device Identifier05414734503693
UDI-Public05414734503693
Combination Product (Y/N)N
Initial Reporter CountryPL
PMA/510(K) Number
P030054
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date (Section B) 05/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date08/31/2015
Device Model NumberCD3211-36
Device Catalogue NumberCD3211-36
Device Lot Number4465982
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2021
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 03/22/2021
Supplement Date Received by Manufacturer04/27/2021
05/16/2021
Initial Report FDA Received Date04/06/2021
Supplement Report FDA Received Date04/27/2021
05/17/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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