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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. 442-2 TORQUE WRENCH; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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ST. JUDE MEDICAL, INC. 442-2 TORQUE WRENCH; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number 442-2
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/29/2023
Event Type  malfunction  
Event Description
It was reported that during a procedure, there was difficulty loosening both screws on a device.It was noted that the torque wrench appeared to be stripped.The torque wrench was replaced, and the procedure was completed with no complications.The patient was stable.
 
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Brand Name
442-2 TORQUE WRENCH
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
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 Key16769419
MDR Text Key313740068
Report Number2017865-2023-17943
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P910023
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 04/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number442-2
Device Catalogue Number442-2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/29/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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