FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 103
MDR report key: 4181249
·
Received October 17, 2014
Report
- Report Number
- 1644487-2014-02737
- Event Type
- Injury
- Date Received
- October 17, 2014
- Date of Event
- November 6, 2012
- Report Date
- September 23, 2014
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VNS PATIENT¿S DEVICE WAS DISABLED DUE TO PAIN AND TENDERNESS OVER THE PATIENT¿S GENERATOR SITE. REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY SHOWED THE PATIENT¿S DEVICE WAS DISABLED ON (B)(6) 2012. THE PATIENT¿S DEVICE WAS PROGRAMMED BACK ON AT THE HOSPITAL ON (B)(6) 2013 WHEN THE PATIENT WAS ADMITTED DUE TO AN INCREASE IN SEIZURES. THE PATIENT¿S DEVICE SETTINGS WERE INCREASED WHILE SHE WAS ADMITTED TO THE HOSPITAL. THE PATIENT¿S DEVICE WAS TESTED DURING AN OFFICE VISIT ON (B)(6) 2013 AND SYSTEM DIAGNOSTICS SHOWED NORMAL DEVICE FUNCTION AT THE TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 660643 | PULSE GEN MODEL 103 | GENERATOR | LYJ | CYBERONICS INC | 103 | 200778 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Hospitalization| R |