BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2841855 · Received November 21, 2012

    Report

    Report Number
    1644487-2012-03091
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY MANUFACTURE, LEAD PIN NOT FULLY INSERTED PAST THE CONNECTER BLOCK OF THE GENERATOR.

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    AN IMPLANT CARD WAS RECEIVED ON (B)(6) 2013. THE IMPLANT INDICATED THAT THE PATIENT UNDERWENT FULL REVISION ON (B)(6) 2013. FOLLOW-UP SHOWED THAT THE WHEN THE PATIENT WAS IN THE OPERATING ROOM, THE DECISION WAS MADE TO CHANGE ALL OF THE EQUIPMENT AS A PROPHYLACTIC REPLACEMENT. THE POST-OPERATIVE IMPEDANCE WAS OKAY. THE EXPLANTED DEVICES WERE DISCARDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PATIENT'S GENERATOR HAS BEEN DISABLED (B)(6) 2012. X-RAYS WERE RECEIVED FOR REVIEW. THE GENERATOR APPEARS IN THE UPPER LEFT CHEST, IN A NORMAL PLACEMENT. THE FILTER FEED-THROUGH WIRES APPEARED TO BE INTACT. THE LEAD CONNECTOR PIN SEEMED TO BE NOT FULLY INSERTED. THE ELECTRODES APPEARED TO BE PLACED IN NORMAL ARRANGEMENT. A STRAIN-RELIEF BEND WAS USED, BUT NO LOOP WAS PRESENT. NO TIE-DOWN WAS USED. THE STRAIN RELIEF BEND APPEARS TO BE TOO SHORT AND A PART THAT APPEARS TO BE BENT COULD BE OBSERVED AT THE LEVEL OF THE LEAD BIFURCATION. PER LABELING, A STRAIN RELIEF BEND SHOULD BE PLACED STARTING 3CM FROM THE ANCHOR TETHER AND SHOULD BE SECURED WITH A TIE-DOWN PARALLEL TO THE ANCHOR TETHER. A LARGE LOOP SHOULD THEN BE FORMED AND SECURED WITH AN ADDITIONAL TIE-DOWN TO ALLOW FOR FULL NECK MOVEMENT IN ALL DIRECTIONS. PART OF THE LEAD WAS BEHIND THE GENERATOR AND COULD NOT BE ASSESSED. THE LEAD WIRES WERE INTACT AT THE INSERTION INTO THE LEAD PIN. BASED ON THE X-RAYS IMAGES, THE HIGH IMPEDANCE CAN BE CAUSED BY THE PIN NOT FULLY INSERTED AND THE BENT PART IN THE LEAD BIFURCATION.

    Description of Event or Problem · 1

    AT THIS TIME NO SURGICAL INTERVENTIONS HAVE BEEN PLANNED.

    Description of Event or Problem · 1

    A VNS PROGRAMMING PHYSICIAN IN FRANCE REPORTED THAT DURING SYSTEM DIAGNOSTIC TESTING THEY FOUND DCDC 7 AND HIGH IMPEDANCE. THE PATIENT WAS IMPLANTED WITH (B)(4) ON (B)(6) 2003. THEY WERE SET AT, ON 30 SEC, OFF 5 MIN, 1,5 MA WITHOUT MAGNET. NO TRAUMA OR MANIPULATION WAS REPORTED PRIOR TO THE REPORTED EVENT. X-RAYS WILL BE SENT TO THE MANUFACTURER FOR REVIEW. A PIN ISSUE HAS NOT BEEN RULED OUT AT THIS TIME. THUS FAR NO FURTHER INFORMATION HAS BEEN ATTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 8861

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR