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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT QUADRA ASSURA MP ICD; NO MATCH
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ABBOTT QUADRA ASSURA MP ICD; NO MATCH Back to Search Results
Model Number CD3371-40C
Device Problem Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Event Description
It was reported the device was explanted and replaced due to an unspecified battery issue.The patient was in stable condition.
 
Manufacturer Narrative
Further information was requested but not received.
 
Manufacturer Narrative
The reported event of premature battery depletion was not confirmed.Longevity analysis revealed the battery depletion to be normal.The telemetry, impedance, sensing, pacing, and high voltage (hv) output functions were tested and revealed to be normal.
 
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Brand Name
QUADRA ASSURA MP ICD
Type of Device
NO MATCH
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer Contact
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key17199246
MDR Text Key317839425
Report Number2017865-2023-24185
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/29/2016
Device Model NumberCD3371-40C
Device Lot Number4466593
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/28/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/12/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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