FDA Adverse Event Injury Summary report: N

PULSE GEN MODEL 102

MDR report key: 2180923 · Received July 22, 2011

Report

Report Number
1644487-2011-01659
Event Type
Injury
Date Received
July 22, 2011
Date of Event
June 24, 2011
Report Date
June 28, 2011
Manufacturer
CYBERONICS, INC.
Product Code
LYJ
PMA / PMN Number
P970003
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
IN, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

ON (B)(6) 2011, CLINIC NOTES FROM A VNS TREATING PHYSICIAN WERE RECEIVED THROUGH CASE MGMT. REVIEW OF THE CLINIC NOTES REVEALED THAT ON (B)(6) 2010, THE PT WAS EXPERIENCING PAIN IN THEIR NECK AND SHOULDERS ON AND OFF. THE PHYSICIAN DECREASED THE VNS PULSE WIDTH TO SEE IF IT WOULD HELP THE PT. THE PHYSICIAN ALSO REPORTED THAT ON (B)(6) 2011 THE PT HAD SEIZURES AT NIGHT, BUT DID NOT TRY AND SWIPE THEIR MAGNET. IN CLINIC NOTES DATED (B)(6) 2011, THE PHYSICIAN REPORTS THAT THE PT HAS A HISTORY OF NECK PAIN. THE PHYSICIAN ALSO REPORTED THAT THE PT HAS RECURRING SPELLS AND IT IS UNK WHETHER THESE ARE BREAKTHROUGH SEIZURES OR NONEPILEPTIC SPELLS. DUE TO THE PT'S FLARE OF SYMPTOMS, THE PHYSICIAN REFERRED THE PT FOR PROPHYLACTIC BATTERY REPLACEMENT. IN CLINIC NOTES DATED (B)(6) 2011, THE PHYSICIAN PROVIDES FURTHER INFO ABOUT THE PT'S HISTORY OF NECK PAIN, STATING THAT IT SPREADS INTO THE OCCIPITAL AREA IN KEEPING WITH NEURALGIA. THE PHYSICIAN AGAIN REPORTS THAT THE PT HAS RECURRING SPELLS AND IT IS UNK WHETHER THESE ARE BREAKTHROUGH SEIZURES OR NONEPILEPTIC SPELLS. THE MFR'S CONSULTANT LATER REPORTED THAT THE PHYSICIAN BELIEVES THE PT'S PAIN WAS NOT RELATED TO VNS. SURGERY HAS NOT YET BEEN SCHEDULED. ATTEMPTS FOR ADDITIONAL INFO REGARDING THE PT'S SEIZURES HAVE BEEN MADE TO THE PHYSICIAN, BUT NO FURTHER INFO HAS BEEN RECEIVED TO DATE. WHEN FURTHER INFO IS RECEIVED, IT WILL BE REPORTED. A BLC PERFORMED WITH THE PROGRAMMING HISTORY IN THE MFR'S PROGRAMMING HISTORY DATABASE WHICH REVEALED NEGATIVE YRS UNTIL ERI = YES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 7272

Patients

Seq Age Sex Outcome Treatment
1 31 YR Required Intervention