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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 Over-Sensing (1438)
Health Effect - Clinical Code Discomfort (2330)
Date of Event 08/19/2019
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
The patient presented in clinic with receiving inappropriate therapy due to post-sensed t-wave oversensing.Technical support was contacted and provided reprogramming suggestions to resolve the event.The device was reprogrammed and 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 Key8955318
Report Number2017865-2019-13190
Device Sequence Number2151115
Product Code NVZ
UDI-Device Identifier05414734503709
UDI-Public05414734503709
Combination Product (Y/N)N
Initial Reporter CountryNO
PMA/510(K) Number
P910023
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/03/2019
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 Date03/31/2015
Device Model NumberCD2211-36Q
Device Lot Number4242676
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 08/19/2019
Initial Report FDA Received Date09/03/2019
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 Other;
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