FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 105
MDR report key: 2211084
·
Received August 5, 2011
Report
- Report Number
- 1644487-2011-01789
- Event Type
- Malfunction
- Date Received
- August 5, 2011
- Date of Event
- July 14, 2011
- Report Date
- July 14, 2011
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED THAT THE PT HAD HIGH IMPEDANCE AT A RECENT APPOINTMENT. THE PT HAD RECENTLY HAD A GENERATOR REPLACEMENT. DIAGNOSTICS WERE WITHIN NORMAL LIMITS FOLLOWING GENERATOR REPLACEMENT (OUTPUT STATUS - OK, IMPEDANCE - OK, IMPEDANCE - 1848 OHMS, ERI - OK). THERE WAS NO REPORTED TRAUMA. X-RAYS WERE TAKEN BUT HAVE NOT BEEN PROVIDED TO THE MFR. SURGERY IS LIKELY BUT HAS NOT OCCURRED AT THIS TIME. GOOD FAITH ATTEMPTS FOR MORE INFO HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 105 | LYJ | CYBERONICS INC | 105 | 2877 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Female |