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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL ST; PERMANENT PACEMAKER ELECTRODE
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL ST; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1888TC/58
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/16/2020
Event Type  malfunction  
Manufacturer Narrative
This product is registered as a combination product.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
It was reported that the patient presented for initial implant.The right ventricular lead was unable to be fixated.After multiple attempts the helix was damaged.The lead was not used and another lead was used instead.The patient was stable post procedure.
 
Manufacturer Narrative
The damage found was sustained during the surgical procedure.The lead was otherwise normal.
 
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Brand Name
TENDRIL ST
Type of Device
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key10787126
MDR Text Key214621916
Report Number2017865-2020-17163
Device Sequence Number1
Product Code NVN
UDI-Device Identifier05414734501705
UDI-Public05414734501705
Combination Product (y/n)N
PMA/PMN Number
P960013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2022
Device Model Number1888TC/58
Device Catalogue Number1888TC-58
Device Lot NumberP000094746
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/16/2020
Initial Date FDA Received11/04/2020
Supplement Dates Manufacturer Received11/20/2020
Supplement Dates FDA Received12/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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