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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT CURRENT+ DR DUAL-CHAMBER ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ABBOTT CURRENT+ DR DUAL-CHAMBER ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD2211-36
Medical Device Problem Code Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/11/2020
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
It was reported that the device went into backup mode following an atrial fibrillation (af) ablation.Abbott technical support was contacted and the device was restored to normal function to resolve the event.Per the request of the patient, the device was explanted and replaced and the patient was in stable condition.
 
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Brand Name
CURRENT+ DR DUAL-CHAMBER ICD
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ABBOTT
645 almanor avenue
sunnyvale CA 94085
MDR Report Key9758863
Report Number2938836-2020-01463
Device Sequence Number618879
Product Code NVZ
UDI-Device Identifier05414734503723
UDI-Public05414734503723
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
P910023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/26/2020
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 Date06/30/2016
Device Model NumberCD2211-36
Device Catalogue NumberCD2211-36
Device Lot NumberS000000047
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 02/11/2020
Initial Report FDA Received Date02/26/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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