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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 Code Over-Sensing (1438)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/10/2019
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
During a follow-up, noise causing automatic mode switch (ams) on the device was noted.The device was reprogrammed.The patient was stable with no adverse consequences.
 
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Brand Name
PROMOTE PLUS CRT-D
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ABBOTT
645 almanor avenue
sunnyvale CA 94085
MDR Report Key8504948
Report Number2938836-2019-02694
Device Sequence Number1920395
Product Code NIK
UDI-Device Identifier05414734503693
UDI-Public05414734503693
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
P910023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/11/2019
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 Date08/31/2015
Device Model NumberCD3211-36
Device Lot Number4475378
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 04/10/2019
Initial Report FDA Received Date04/11/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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