FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 103
MDR report key: 4200536
·
Received October 24, 2014
Report
- Report Number
- 1644487-2014-02825
- Event Type
- Injury
- Date Received
- October 24, 2014
- Date of Event
- August 29, 2014
- Report Date
- September 29, 2014
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AFTER RECENTLY BEING IMPLANTED. THE PATIENT UNDERWENT EMERGENCY EXPLANT SURGERY. DURING THE EXPLANT THE PATIENT'S ARTERY WAS TORN AND THE PATIENT SUSTAINED SIGNIFICANT BLOOD LOSS WHICH REQUIRED A BLOOD TRANSFUSION. THE EXPLANTED LEAD AND CUT PORTION OF THE LEAD WERE DISCARDED DURING THE SURGERY. NO REIMPLANT IS PLANNED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 678860 | PULSE GEN MODEL 103 | GENERATOR | LYJ | CYBERONICS INC | 103 | 202803 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Other| R |