FDA Adverse Event Injury Summary report: N

PULSE GEN MODEL 103

MDR report key: 1892062 · Received October 26, 2010

Report

Report Number
1644487-2010-02406
Event Type
Injury
Date Received
October 26, 2010
Date of Event
September 1, 2010
Report Date
September 27, 2010
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

Description of Event or Problem · 1

IT WAS INITIALLY REPORTED BY THE PHYSICIAN THAT THE PT HAD DEVELOPED HEMATOMAS ON THE NECK AND CHEST FOLLOWING IMPLANT SURGERY. THE HEMATOMAS WERE DRAINED AND APPROX 1 1/2 DAYS LATER, TWO ADDITIONAL DEVELOPED AT THE NECK AND CHEST SITES. IT WAS THEN NOTED THAT THE HEMATOMAS WOULD BE MONITORED TO SEE IF THEY WOULD RESOLVE. THERE WAS NO ASSOCIATED INFECTION PRESENT. THE PHYSICIAN STATED THAT PRIOR TO SURGERY, PT WAS ON COUMADIN AND ASPIRIN DAILY. THE PT HAD ADDITIONAL MEDICATIONS, LOVENOX AND ASA, ADDED IMMEDIATELY AFTER SURGERY BUT PRIOR TO THE HEMATOMAS DEVELOPING. THE PT WAS SCHEDULED TO HAVE THEIR VNS DEVICE TURNED ON TWO WEEKS POST-SURGERY. AT THE F/U VISIT, THE PHYSICIAN NOTED THAT THE HEMATOMAS HAD RESOLVED AND NO ADDITIONAL HEMATOMAS HAD DEVELOPED. THE PT WAS ABLE TO TOLERATE SETTINGS WELL AND HAD GOOD SEIZURE CONTROL. NO ADDITIONAL ADVERSE EFFECTS WERE REPORTED. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 2709

Patients

Seq Age Sex Outcome Treatment
1 67 YR Required Intervention