FDA Adverse Event
Malfunction
Summary report: N
HOLTER VALVE AND CATHETER
MDR report key: 191369
·
Received October 13, 1998
Report
- Report Number
- 1219655-1998-00183
- Event Type
- Malfunction
- Date Received
- October 13, 1998
- Date of Event
- December 19, 1998
- Manufacturer
- JOHNSON & JOHNSON PROFESSIONAL, INC.
- Product Code
- JXG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
JJPI WAS NOTIFIED OF THIS INCIDENT THROUGH A SUMMONS AND COMPLAINT LAWSUIT. THE SUIT ALLEDGES, "THAT THE SHUNT ON JANUARY 25, 1997, ....IMPLANTED INTO THE PLANTIFF'S DECEDENT FAILED CAUSING PLANTIFF'S DECEDENT TO SUFFER AND SUSTAIN SEVERE BODILY INJURIES LEADING TO HIS DEATH". THE PATIENT'S HEALTH HISTORY AND EXACT CAUSE OF DEATH IS UNKNOWN. NO OTHER INFORMATION CONCERNING THE INCIDENT IS KNOWN AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOLTER VALVE AND CATHETER Implant | SHUNT, VENTRICULAR-PERITONEAL | JXG | JOHNSON & JOHNSON PROFESSIONAL, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death | VENTRICULAR CATHETER, PRODUCT CODE 82-1664 |