BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 4242367 · Received November 11, 2014

    Report

    Report Number
    1644487-2014-02982
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 20, 2014
    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
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN BY THE PHYSICIAN AFTER THE RECENT REPOSITIONING AND NO COMPLAINTS WERE VOICED BY THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS HAVING NECK PAIN AND PROTRUSION OF A TIE DOWN AT THE NECK SITE. THE PATIENT WAS REFERRED FOR SURGICAL REPOSITIONING. CLINIC NOTES WERE RECEIVED DATED (B)(4) 2014 THAT INDICATED THE PATIENT FEELS THE BATTERY IS DRIFTED TO THE LEFT AND IS CAUSING PAIN. THE PHYSICIAN NOTED THAT THERE HAVE BEEN NO SEIZURES SINCE THE PATIENT¿S LAST VISIT. THE PATIENT LATER REPORTED AN INFECTION AT THE GENERATOR SITE ON (B)(6) 2014. IT WAS NOTED THAT IT WAS BELIEVED THAT THE PROTRUSION AND INFECTION WERE RELATED. THE PRIMARY CARE PHYSICIAN HAD GIVEN HER ANTIBIOTICS. THE PATIENT UNDERWENT SURGERY TO REPOSITION THE GENERATOR ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT DID NOT IN FACT HAVE AN INFECTION, PER THE SURGEON. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION FROM THE PHYSICIAN WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726853 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS, INC. 105 202808

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention