Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT CURRENT+ DR DUAL-CHAMBER ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT CURRENT+ DR DUAL-CHAMBER ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD2211-36
Medical Device Problem Codes Signal Artifact/Noise (1036); Failure to Charge (1085)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/28/2013
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 follow-up, an alert for shorted output stage detection (sosd) was observed in the history of the device.Abbott technical support was contacted and determined that the sosd alert was most likely false and caused by electromagnetic interference.No intervention was performed; the patient was in stable condition and there were no adverse consequences.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9696036
Report Number2938836-2020-01082
Device Sequence Number11478219
Product Code NVZ
UDI-Device Identifier05414734503723
UDI-Public05414734503723
Combination Product (Y/N)N
Initial Reporter CountryPL
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) 02/11/2020
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 Date08/31/2014
Device Model NumberCD2211-36
Device Catalogue NumberCD2211-36
Device Lot Number3981349
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 02/03/2020
Initial Report FDA Received Date02/11/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-