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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL STS; PERMANENT PACEMAKER ELECTRODE
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL STS; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 2088TC/58
Device Problems High impedance (1291); Difficult to Insert (1316); Failure to Advance (2524); Capturing Problem (2891)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/22/2021
Event Type  malfunction  
Event Description
It was reported that the patient present for an implant procedure.During the procedure the right ventricular (rv) lead exhibited a high capture threshold along with an increase in impedance.There was also difficulty in inserting a different stylet into the lead.The physician opted to replace the lead, a new lead was successfully implanted.The patient was in stable condition.
 
Manufacturer Narrative
The damage found was sustained during procedure.The lead was otherwise normal.
 
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Brand Name
TENDRIL STS
Type of Device
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key11823090
MDR Text Key250612958
Report Number2017865-2021-17981
Device Sequence Number1
Product Code NVN
UDI-Device Identifier05414734502894
UDI-Public05414734502894
Combination Product (y/n)Y
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 06/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2023
Device Model Number2088TC/58
Device Catalogue Number2088TC-58
Device Lot NumberP000116380
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2021
Was the Report Sent to FDA? No
Date Manufacturer Received05/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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