FDA Adverse Event Death Summary report: N

DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

MDR report key: 10849657 · Received November 17, 2020

Report

Report Number: 2017865-2020-17681
Event Type: Death
Date Received: November 17, 2020
Date of Event: November 8, 2020
Report Date: November 16, 2020
Manufacturer: ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
Product Code: NVY
UDI-DI: 05414734503167
PMA / PMN Number: P950022
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: 117

Narratives

Additional Manufacturer Narrative · 1

PATIENT PHYSICIAN NAME WAS PROVIDED - DR. (B)(6) AT (B)(6) MEDICAL CENTER. 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.

Description of Event or Problem · 1

RELATED MANUFACTURER REPORT NUMBER: 2017865-2020-17678; 2017865-2020-17679; 2017865-2020-17680. IT WAS REPORTED THAT THE ATRIAL AND VENTRICULAR OUTPUTS WERE OBSERVED REMOTELY TO HAVE AN ALERT FOR HIGH OUTPUTS. SHORTLY THEREAFTER IT WAS LEARNED THAT THE PATIENT HAD PASSED AWAY. IT WAS QUESTIONED WHY AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SHOCK WAS NOT RECEIVED. REVIEW OF ONLINE ELECTROCARDIOGRAMS NOTED NON SUSTAINED ACTIVITY THAT LOOKED LIKE VENTRICULAR FIBRILLATION. FURTHER EVALUATION DETERMINED THE DEVICE HAD FUNCTIONED NORMALLY BUT THE VENTRICULAR FIBRILLATION WAS SO FINE THAT IT COULD NOT BE PROPERLY SENSED. ADDITIONAL INFORMATION SUGGESTS THE PATIENT MAY NOT HAVE RECEIVED A DEFIBRILLATION THRESHOLD TEST AT IMPLANT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1315508	DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR	DEFIBRILLATION LEAD	NVY	ST. JUDE MEDICAL, INC.(CRM-SYLMAR)	7121Q/58	3381978	05414734503167

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR		Death	QUICKFLEX LV LEAD.\| TENDRIL STS.\| UNIFY ASSURA CRT-D RF HV.