FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 3123510
·
Received May 22, 2013
Report
- Report Number
- 1644487-2013-01529
- Event Type
- Injury
- Date Received
- May 22, 2013
- Date of Event
- March 7, 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
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THE PATIENT HAD VNS GENERATOR REPLACEMENT SURGERY ON (B)(6) 2013. ALL ATTEMPTS FOR FURTHER INFORMATION FROM THE REPORTER HAVE BEEN UNSUCCESSFUL TO DATE. ALL ATTEMPTS FOR RETURN OF THE EXPLANTED GENERATOR HAVE ALSO BEEN UNSUCCESSFUL TO DATE. AN IMPLANT CARD WAS RECEIVED TO THE MANUFACTURER INDICATING THE GENERATOR WAS REPLACED FOR PROPHYLACTIC REASONS.
Description of Event or Problem · 1
REPORTER INDICATED VIA CLINIC NOTES RECEIVED TO THE MANUFACTURER DATED (B)(6) 2013 THAT A PATIENT WAS EXPERIENCING DELAYED POST-RECOVERY TIME AFTER SEIZURES, AND TWO EVENTS OF SYNCOPE THAT DO NOT APPEAR TO BE SEIZURE-RELATED. THE PATIENT¿S CONDITION WAS DOCUMENTED AS STABLE AT THIS TIME. SURGERY TO REPLACE THE VNS GENERATOR IS TENTATIVELY PLANNED FOR (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 225862 | PULSE GEN MODEL 102 | GENERATOR | LYJ | CYBERONICS INC | 102 | 014628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |