BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFY

    MDR report key: 1051098 · Received May 22, 2008

    Report

    Report Number
    6000153-2008-02756
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 1, 2017
    Manufacturer
    NEURO - VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Additional Manufacturer Narrative · 1

    SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 37711 LOT# SERIAL# (B)(4) IMPLANTED: (B)(6) 2007 EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR H6. THE CONCLUSION CODE 67 NO LONGER APPLIES. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AFTER BEING ASSAULTED AT WORK, THE PATIENT'S RIGHT LEG WOULD SEIZE WHEN THE IMPLANTABLE NEUROSTIMULATOR WAS TURNED ON. THE PATIENT GOT GOOD PAIN RELIEF, BUT THE LEG SEIZING RESULTED IN AN INABILITY TO WALK. THE PATIENT'S SYMPTOMS WERE UNCHANGED AFTER 2 REPROGRAMMING SESSIONS. THE HCP RECOMMENDED PHYSICAL THERAPY. IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR WAS SUCCESSFULLY REPROGRAMMED AND THE PATIENT WAS VERY HAPPY AFTERWARDS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED 6.5 YEARS LATER REPORTED THAT THE SPINAL CORD STIMULATOR (SCS) SYSTEM WAS REPLACED ON (B)(6) 2009. WHEN SHE WAS ASSAULTED, HER WIRES WERE DAMAGED. THEY REPLACED THE LEADS AND THE IMPLANTABLE NEUROSTIMULATOR (INS) AND SHE HAD A SMALLER INS IMPLANTED. IT WAS NOTED THAT HER INS WAS ABOUT THE SIZE OF A DECK OF CARDS, AND SHE HAD PROBLEMS CATCHING IT ON THINGS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER ON 2017-05-01 REPORTING THAT THE FIRST IMPLANT WAS IN 2005 WHICH WAS NOT WHAT REGISTRATION SHOWED. REGISTRATION SHOWED 2007. DUE TO THIS, IT WAS NOTED THAT THE EVENT DATES WERE UNKNOWN. IT WAS STATED THAT ALL THE CONSUMER KNEW WAS THAT THEY HAD A TOTAL OF 4 SURGERIES RELATED TO THE DEVICE: THE FIRST WAS THE TRIAL INSERT, THE SECOND WAS THE ORIGINAL IMPLANT SURGERY, THE THIRD WAS DUE TO A DAMAGED LEAD, AND THE FOURTH WAS WHEN THE IMPLANT WAS MOVED TO A DIFFERENT LOCATION. (SEE MDR# 3004209178-2013-01024 FOR THE POCKET REVISION SURGERY). IT WAS STATED THAT THE FIRST IMPLANT THE PATIENT HAD WAS SO LARGE THAT WHEN THEY WERE IN A BATHING SUIT THE DEVICE COULD BE SEEN BULGING OUT. THE PATENT HAD BEEN ATTACKED AND THROWN TO THE GROUND WHICH RESULTED IN THE LEAD BEING DAMAGED AND BROKEN. THIS WAS FIRST REPORTED TO HAVE BEEN IN 2005 OR 2006 BUT THEN CLARIFIED THAT THEY DID NOT KNOW. THE PATIENT WAS NOT SURE IF THE IMPLANT WAS COMPLETELY REPLACED AT THE TIME OF THE LEAD DAMAGE OR IF THE HEALTH CARE PROFESSIONAL (HCP) JUST SURGICALLY REVISED THE LEADS AND LEFT THE BATTERY IN. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECIFY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW NEURO - VILLALBA 3998 V008387

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention IMPLANTED:| PROGRAMMER MODEL 37742 LOT# NJD046599N| SERIAL # (B)(4)| EXPLANTED: