FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 2241438
·
Received August 18, 2011
Report
- Report Number
- 1644487-2011-01879
- Event Type
- Malfunction
- Date Received
- August 18, 2011
- Date of Event
- July 19, 2011
- Report Date
- July 19, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT IT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
A PHYSICIAN REPORTED THAT THE PATIENT HAD HIGH IMPEDANCE. THE PATIENT'S SETTINGS HAD NOT BEEN CHANGED SINCE (B)(6) 2011, BUT THE PATIENT DID HAVE A SEIZURE TYPE INVOLVING A HEAD DROP. A FEW WEEKS PRIOR, THE PATIENT HAD AN ATONIC HEAD DROP WHERE THE NECK SEEMED TO BE STRAINED IN ITS POSITION. THE PHYSICIAN STATED THAT A REVISION SURGERY IN THE FUTURE WAS LIKELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 302-20 | 201132 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Male |