FDA Adverse Event
Death
Summary report: N
ST. JUDE MEDICAL 3365-40Q QUADRA ASURA
MDR report key: 8935190
·
Received August 26, 2019
Report
- Report Number
- MW5089321
- Event Type
- Death
- Date Received
- August 26, 2019
- Date of Event
- August 22, 2019
- Report Date
- August 23, 2019
- Manufacturer
- ST. JUDE MEDICAL ABBOTT MEDICAL
- Product Code
- LWS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- VA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT HAD ICD IMPLANT. DEVICE DETECTED AND TREATED VT THE FIRST TIME. THEN THE DEVICE STORED EPISODES THAT IT THOUGHT WAS "NOISE" BUT WAS MOST LIKELY POLYMORPHIC VT AND THE DEVICE DID NOT TREAT IT. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 726992 | ST. JUDE MEDICAL 3365-40Q QUADRA ASURA | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | ST. JUDE MEDICAL ABBOTT MEDICAL | |||
| 726993 | LV LEAD 1459Q QUARTET | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | ST. JUDE MEDICAL ABBOTT MEDICAL | |||
| 726994 | RV LEAD 7122Q DURATA SJ4 | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | ST. JUDE MEDICAL ABBOTT MEDICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Death |