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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT CD2215-36Q CURRENT ACCEL DR ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ABBOTT CD2215-36Q CURRENT ACCEL DR ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD2215-36Q
Medical Device Problem Code Premature Discharge of Battery (1057)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/31/2019
Type of Reportable Event Serious Injury
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 in clinic, the device was noted to be at elective replacement indicator (eri).The physician alleges premature battery depletion.The device was explanted and replaced.The patient was stable with no consequences.
 
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Brand Name
CD2215-36Q CURRENT ACCEL DR ICD
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ABBOTT
645 almanor avenue
sunnyvale CA 94085
MDR Report Key9315373
Report Number2938836-2019-16231
Device Sequence Number10902801
Product Code NVZ
UDI-Device Identifier05414734503075
UDI-Public05414734503075
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
P910023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/13/2019
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 Date08/31/2013
Device Model NumberCD2215-36Q
Device Lot Number3634727
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 10/31/2019
Initial Report FDA Received Date11/13/2019
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 Hospitalization; Required Intervention;
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