FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 105
MDR report key: 3122047
·
Received May 21, 2013
Report
- Report Number
- 1644487-2013-01489
- Event Type
- Injury
- Date Received
- May 21, 2013
- Date of Event
- March 18, 2013
- Report Date
- April 26, 2013
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
CLINIC NOTES WERE RECEIVED IN REGARDS TO A VNS PATIENT. THE PATIENT WAS SEEN (B)(6) 2013 AND IT WAS REPORTED THAT HE HAD 2 SEIZURES TODAY FIVE MINUTES APART AND THAT HE COULD NOT SLEEP FOR THE PAST 2 DAYS DUE TO STRESS HOWEVER, HE DID NOT MISS A DOSE OF MEDICATION. THE PATIENT WAS STILL HAVING BREAKTHROUGH SEIZURES, INSOMNIA. THEY WERE ON KLONOPON 1MG EVERY 8 HRS AS NEEDED. AND WAS TO FOLLOWUP IN TWO WKS. PRIOR TO THIS EVENT, THEY HAD NO RECURRENCE OF SEIZURES; HE USES THE MAGNET ONCE A DAY. GOOD FAITH ATTEMPTS ARE UNDERWAY FOR FURTHER DETAILS ABOUT THE REPORTED EVENT. NO FURTHER INFORMATION HAS BEEN ATTAINED AT THIS TIME.
Description of Event or Problem · 1
NO FURTHER INFORMATION HAS BEEN ATTAINED AFTER GOOD FAITH ATTEMPTS HAVE BEEN MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224009 | PULSE GEN MODEL 105 | PULSE GEN MODEL 105 | LYJ | CYBERONICS, INC. | 105 | 3486 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other |