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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) OPTISENSE; No Match

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) OPTISENSE; No Match Back to Search Results
Model Number 1699TC
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Event Description
Voluntary medwatch report received noted that the right ventricular lead was capped due to an unknown product performance issue.No patient consequences were reported.
 
Manufacturer Narrative
Voluntary medwatch report received: mw5148775.
 
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Brand Name
OPTISENSE
Type of Device
No Match
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key18455935
MDR Text Key332206790
Report Number2017865-2024-00524
Device Sequence Number1
Product Code NVN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P960013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial
Report Date 01/05/2024
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
Device Operator Health Professional
Device Model Number1699TC
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/22/2023
Initial Date FDA Received01/05/2024
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
Patient Outcome(s) Required Intervention;
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