FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 3062708
·
Received April 17, 2013
Report
- Report Number
- 1644487-2013-01040
- Event Type
- Malfunction
- Date Received
- April 17, 2013
- Date of Event
- March 4, 2013
- Report Date
- March 19, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF MANUFACTURER DEVICE HISTORY RECORD. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
REPORTER INDICATED VIA THE MANUFACTURER'S IMPLANT CARD THAT THE PATIENT'S VNS LEAD AND GENERATOR WERE REPLACED ON (B)(6) 2013 DUE TO HIGH LEAD IMPEDANCE. MANUFACTURER REVIEW OF THE LEAD DEVICE HISTORY RECORD DOCUMENTS THE LEAD MET ALL FINAL TESTING PRIOR TO DISTRIBUTION. ATTEMPTS FOR ADDITIONAL INFORMATION AND RETURN OF THE EXPLANTED DEVICES ARE IN PROGRESS.
Description of Event or Problem · 1
ALL ATTEMPTS TO THE TREATING PHYSICIAN FOR ADDITIONAL INFORMATION AND DISPOSITION OF THE EXPLANTED DEVICES HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 165133 | LEAD MODEL 302 | LEAD | LYJ | CYBERONICS INC | 302-20 | 200867 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR |