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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PASSIVE PLUS DX; No Match
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PASSIVE PLUS DX; No Match Back to Search Results
Model Number 1346T/58
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Event Description
It was reported that the right ventricular lead was previously capped on (b)(6) 2015 for an unknown reason.The lead was explanted and replaced on (b)(6) 2023.No patient consequences were reported.
 
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Brand Name
PASSIVE PLUS DX
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 Key18544672
MDR Text Key333264001
Report Number2017865-2024-01505
Device Sequence Number1
Product Code NVN
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P960030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 01/19/2024
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 Expiration Date12/31/2003
Device Model Number1346T/58
Device Lot Number0002419044
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/15/2024
Initial Date FDA Received01/19/2024
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
Treatment
FORTIFY; TENDRIL
Patient Outcome(s) Required Intervention;
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