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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT PROMOTE+ CRT-D W/SJ4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ABBOTT PROMOTE+ CRT-D W/SJ4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3211-36Q
Medical Device Problem Code Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code Therapeutic Effects, Unexpected (2099)
Date of Event 10/30/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event or Problem Description
The patient presented in clinic after receiving inappropriate defibrillation therapy for supraventricular tachycardia.The physician did not allege a malfunction against the device and stated the device performed as expected based upon its programmed settings.Technical support was contacted and the device was reprogrammed to resolve the event.The patient was in stable condition.
 
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Brand Name
PROMOTE+ CRT-D W/SJ4 CONNECTOR
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ABBOTT
645 almanor avenue
sunnyvale CA 94085
MDR Report Key10945235
Report Number2938836-2020-09505
Device Sequence Number3489531
Product Code NIK
UDI-Device Identifier05414734503679
UDI-Public05414734503679
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
P030054
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/03/2020
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
Operator of Device Health Professional
Device Expiration Date01/31/2016
Device Model NumberCD3211-36Q
Device Catalogue NumberCD3211-36Q
Device Lot Number4701615
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/18/2020
Initial Report FDA Received Date12/04/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
TENDRIL STS
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