FDA Adverse Event
Death
Summary report: N
ST JUDE MEDICAL
MDR report key: 3738563
·
Received April 4, 2014
Report
- Report Number
- 3738563
- Event Type
- Death
- Date Received
- April 4, 2014
- Date of Event
- March 31, 2014
- Report Date
- April 1, 2014
- Manufacturer
- ST JUDE MEDICAL
- Product Code
- LWS
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- VA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT AT HOME AND HAD A EPISODE OF VENTRICULAR FIB AND THE DEVICE (IC) ATTEMPTED TO TREAT. DEVICE FAILED TO CONVERT RHYTHM AND SUBSEQUENTLY IDENTIFIED THE REMAINDERS OF EPISODES AS NOISE AND WITHHELD TREATMENT. PT EXPIRED. MFR NOTIFIED. RV LEAD WAS A CLASS 1 FDA RECALL IN (B)(6) 2011. LV LEAD WAS A CLASS 2 FDA RECALL IN (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 205439 | ST JUDE MEDICAL | ICD | LWS | ST JUDE MEDICAL | 3257-40 UNIFYASSURE | ||
| 205440 | ST JUDE MEDICAL | LEAD (RA) | LWS | ST JUDE MEDICAL | 1788TC | ||
| 205441 | ST JUDE MEDICAL | LEAD (LV) | LWS | ST JUDE MEDICAL | 1058T | ||
| 205442 | ST JUDE MEDICAL | LEAD (RV) | LWS | ST JUDE MEDICAL | 7001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Death |