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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT CURRENT+ DR DUAL-CHMBR W/SJ4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ABBOTT CURRENT+ DR DUAL-CHMBR W/SJ4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD2211-36Q
Medical Device Problem Code Tactile Prompts/Feedback (4022)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/28/2021
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 in clinic, a loss of patient vibratory alert was noted on the device.No intervention was performed.The patient was stable.
 
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Brand Name
CURRENT+ DR DUAL-CHMBR W/SJ4 CONNECTOR
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
MDR Report Key12158555
Report Number2017865-2021-25613
Device Sequence Number4215251
Product Code NVZ
UDI-Device Identifier05414734503709
UDI-Public05414734503709
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
P910023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/13/2021
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 NumberCD2211-36Q
Device Catalogue NumberCD2211-36Q
Device Lot Number4501044
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 06/28/2021
Initial Report FDA Received Date07/13/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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