FDA Adverse Event Injury Summary report: N

PULSE GEN MODEL UNK

MDR report key: 2803298 · Received October 24, 2012

Report

Report Number: 1644487-2012-02715
Event Type: Injury
Date Received: October 24, 2012
Date of Event: July 9, 2012
Report Date: September 26, 2012
Manufacturer: CYBERONICS
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

A VNS PATIENT REPORTED TO THE SURGEON'S OFFICE THAT HER VNS GENERATOR WAS TURNED OFF. IT WAS REPORTEDLY ON FOR A LITTLE OVER A WEEK BEFORE SHE HAD A NERVOUS BREAKDOWN BECAUSE SHE COULD NOT STAND THE TURNING ON AND OFF OF THE DEVICE. SHE WAS IMPLANTED ON (B)(6) 2012, AND THE DEVICE WAS TURNED OFF ON (B)(6) 2012. THE PATIENT STATED TO THE SURGEON'S OFFICE TO IN THE FUTURE "NOT TO IMPLANT PATIENTS WHO ARE CRAZY LIKE HERSELF." THE PATIENT IS BIPOLAR AND TAKES A LOT OF MEDICATION FOR HER BIPOLAR ISSUE PER THE SURGEON'S OFFICE. THEREFORE, THE SURGEON'S OFFICE REPORTED THAT THE PATIENT WAS NOT GEARED TO HAVE VNS IMPLANTED. SHE WAS TRYING TO HAVE HER BIPOLAR ISSUES TREATED, AND THEN SHE WILL HAVE HER VNS TURNED ON. THE SURGEON'S OFFICE ADVISED THE PATIENT TO TRY AND TURN THE DEVICE ON AGAIN IN THE FUTURE. ATTEMPTS FOR INFORMATION FROM THE REFERRING PHYSICIAN WERE UNSUCCESSFUL. THE PHYSICIAN REPORTED THAT HE DOES NOT HAVE ADDITIONAL INFORMATION AS HE NEVER TURNED HER DEVICE ON OR OFF AND NEVER PERFORMED DIAGNOSTICS. THE PATIENT WAS REPORTEDLY BEING TREATED BY A NON-VNS PHYSICIAN. ATTEMPTS FOR INFORMATION FROM THAT PHYSICIAN HAVE BEEN UNSUCCESSFUL. ADDITIONALLY, ATTEMPTS FOR PRODUCT INFORMATION FROM THE IMPLANTING FACILITY HAVE BEEN UNSUCCESSFUL TO DATE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PULSE GEN MODEL UNK	GENERATOR	LYJ	CYBERONICS	ASKU	NI

Patients

Seq	Age	Sex	Outcome	Treatment
1	40 YR		Required Intervention