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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL STS; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL STS; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number 2088TC/52
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 04/30/2020
Event Type  Death  
Manufacturer Narrative
This product is registered as a combination product.The investigation results will be provided in the final report.
 
Event Description
Related manufacturer reference number: 2017865-2020-07332, 2017865-2020-07334, 2017865-2020-07336.It was reported that the patient has deceased. there is no known allegation from a health care professional that suggests that the death was device related. the cause of death was unknown. no additional information was reported.
 
Manufacturer Narrative
A partial lead with the connector portion measuring 6.7 cm was returned for analysis.The damage found was sustained during the surgical procedure.The portion of the lead that was returned was otherwise normal.Without return of the entire lead, a complete analysis could not be performed.
 
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Brand Name
TENDRIL STS
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key10136445
MDR Text Key194591168
Report Number2017865-2020-07338
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734502887
UDI-Public05414734502887
Combination Product (y/n)N
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 07/05/2020
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? No
Device Operator Health Professional
Device Expiration Date01/31/2022
Device Model Number2088TC/52
Device Catalogue Number2088TC-52
Device Lot NumberA000075385
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/21/2020
Initial Date FDA Received06/09/2020
Supplement Dates Manufacturer Received06/16/2020
Supplement Dates FDA Received07/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; QUADRA ASSURA MP ICD; QUARTET; DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; QUADRA ASSURA MP ICD; QUARTET
Patient Outcome(s) Death;
Patient Age84 YR
Patient Weight91
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