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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DURATA STS OPTIM ACTIVE FIXATION; Implantable cardioverter defibrillator (non-CRT)
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ABBOTT DURATA STS OPTIM ACTIVE FIXATION; Implantable cardioverter defibrillator (non-CRT) Back to Search Results
Model Number 7120/65
Device Problem Capturing Problem (2891)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2023
Event Type  Injury  
Event Description
It was reported that after the patient fell increased capture threshold was observed on the right ventricular (rv) lead.The rv lead explanted and replaced to resolve the event.The patient was stable and there were no adverse consequences.
 
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Brand Name
DURATA STS OPTIM ACTIVE FIXATION
Type of Device
Implantable cardioverter defibrillator (non-CRT)
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 Key18507796
MDR Text Key332834353
Report Number2017865-2024-01037
Device Sequence Number1
Product Code LWS
UDI-Device Identifier05414734502092
UDI-Public05414734502092
Combination Product (y/n)Y
Reporter Country CodeGM
PMA/PMN Number
P950022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 01/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2012
Device Model Number7120/65
Device Lot Number2921803
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/20/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/14/2009
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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