BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 2854766 · Received December 3, 2012

    Report

    Report Number
    1644487-2012-03176
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    July 17, 2012
    Report Date
    November 8, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO OUR CONSULTANT THAT A VNS PATIENT WILL BE HAVING A BATTERY REPLACEMENT TO A SMALLER MODEL. THE SURGERY WILL BE PERFORMED BECAUSE WHEN SHE SHAKES HER LEFT ARM IT IS IRRITATING HER SHE HAS NUMBNESS AND TINGLING DOWN HER LEFT ARM. HER NEUROLOGIST BELIEVES THE IMPLANT IS NEXT TO BRACHIAL PLEXIUS AND SHE WOULD BENEFIT FROM RE-POSITION (AND A SMALLER DEMIPULSE). THE PATIENT WILL BE SCHEDULED FOR SURGERY IN (B)(6) 2013.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT, SINCE REVISION, THE PAIN RADIATING DOWN THE PATIENT¿S ARM WAS NO LONGER OCCURRING.

    Description of Event or Problem · 1

    THE PATIENT'S EXPLANTED PRODUCTS HAVE NOT BEEN RETURNED FOR ANALYSIS AFTER GOOD FAITH ATTEMPTS HAVE BEEN MADE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WENT TO SURGERY. THEY DECIDED TO DO A COMPLETE REVISION INCLUDING A PROPHYLACTIC BATTERY CHANGE. THE PATIENT REPORTED PAIN AND THE DECISION WAS MADE TO REPLACE THE GENERATOR FOR A SMALLER GENERATOR. THEY SUSPECTED A LEAD ISSUE RELATED TO HER INITIAL COMPLAINT OF PAIN (NECK) AND THE POCKET WAS ALREADY WIDE FOR THE BIGGER GENERATOR (IE DID NOT WANT THE DEMIPULSE TO POTENTIALLY FLOAT IN THE LARGER POCKET) PRIOR TO THE SURGERY THE DEVICE WAS INTERROGATED AND THE RESULTS WERE NORMAL AND EOS=NO. HOWEVER, THE SURGEON REPORTED A SLIT IN THE LEAD INSULATION. IT WAS UNKNOWN IF THE SLIT WAS MADE BY THE SURGEON DURING THE SURGERY OR IF IT WAS THERE PRIOR TO THE SURGERY. IT IS UNKNOWN IF THE LEAD BODY WILL BE RETURNED FOR ANALYSIS. AT THIS TIME THE GENERATOR IS BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R PULSE GEN MODEL 102R LYJ CYBERONICS, INC. 102R 200929

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other