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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/52
Device Problem Difficult To Position (1467)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/06/2018
Event Type  malfunction  
Event Description
It was reported that during the implant procedure, the lead exhibited an operational issue upon positioning and could not be repositioned.The lead was not used, and another lead was implanted.The patient¿s condition post procedure was stable.
 
Manufacturer Narrative
The damage found was sustained during the surgical 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
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key7453228
MDR Text Key106246782
Report Number2017865-2018-05982
Device Sequence Number1
Product Code NVN
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
P960013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2020
Device Model Number2088TC/52
Device Lot NumberP000054862
Other Device ID Number05414734502887
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/13/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/24/2017
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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