FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 4221705
·
Received November 3, 2014
Report
- Report Number
- 1644487-2014-02906
- Event Type
- Malfunction
- Date Received
- November 3, 2014
- Date of Event
- September 24, 2014
- Report Date
- October 6, 2014
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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
IT WAS REPORTED THAT THE EXPLANTING FACILITY WILL NOT RETURN THE EXPLANTED DEVICES; THEREFORE, NO ANALYSIS CAN BE PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VNS PATIENT¿S DEVICE WAS TESTED DURING AN OFFICE VISIT ON (B)(6) 2014 AND DIAGNOSTICS REVEALED HIGH IMPEDANCE (DC DC ¿ 7). THE PATIENT¿S DEVICE WAS NOT DISABLED. THE PATIENT¿S DEVICE WAS TESTED AGAIN ON (B)(6) 2014 AND TWO SYSTEM DIAGNOSTICS SHOWED HIGH IMPEDANCE. X-RAYS WERE TAKEN AND WERE REPORTED BY THE PHYSICIAN TO BE UNREMARKABLE. THE PATIENT UNDERWENT GENERATOR AND LEAD REPLACEMENT SURGERY ON (B)(6) 2014. THE EXPLANTED GENERATOR AND LEAD HAVE NOT BEEN RETURNED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 702434 | BIPOL LEAD MODEL 300 | LEAD | LYJ | CYBERONICS, INC. | 300-20 | 37270C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR |