FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL UNKNOWN
MDR report key: 4173982
·
Received October 15, 2014
Report
- Report Number
- 1644487-2014-02697
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Date of Event
- June 24, 2004
- Report Date
- September 19, 2014
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
DURING REVIEW OF THE IN-HOUSE PROGRAMMING/DIAGNOSTIC HISTORY DATABASE, IT WAS OBSERVED THAT HIGH IMPEDANCE WAS OBSERVED AT OFFICE VISIT ON (B)(6) 2012. IT IS UNKNOWN IF ANY PATIENT MANIPULATION OR TRAUMA OCCURRED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE READING. IT IS UNKNOWN IF SURGERY HAS BEEN PERFORMED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 656012 | LEAD MODEL UNKNOWN | LEAD | LYJ | CYBERONICS INC | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |