FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL UNK
MDR report key: 1311569
·
Received February 10, 2009
Report
- Report Number
- 1644487-2009-00232
- Event Type
- Injury
- Date Received
- February 10, 2009
- Date of Event
- January 7, 2009
- Report Date
- January 7, 2009
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ELLEN LR, ET. AL. " MANAGEMENT OF VAGAL NERVE STIMULATOR INFECTIONS: DO THEY NEED TO BE REMOVED.?" J NEUROSURG PEDIATRICS 3, 73-78, 2009.
Description of Event or Problem · 1
REPORTER INDICATED VIA LITERATURE A VNS THERAPY PATIENT EXPERIENCED AN INFECTION AT THE GENERATOR SITE AND UNDERWENT EXPLANT SURGERY. CULTURES WERE POSITIVE FOR S. AUREUS. THE PATIENT PRESENTED WITH ERYTHEMA, WOUND BREAKDOWN AND LYMPHADENOPATHY AND WAS TREATED WITH CEPH, WOUND REVISION AND IV TO PO CIPRO. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL UNK | LYJ | CYBERONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |