BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 2945831 · Received February 6, 2013

    Report

    Report Number
    3006630150-2013-00203
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: MODEL #: SC-1110-02 SERIAL/LOT#: (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG). THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT NEUROLOGICAL DEFICITS OCCURRED OVER THE COURSE OF ONE WEEK AFTER THE IMPLANT PROCEDURE. THE PHYSICIAN IS NOT CERTAIN, BUT FEELS THAT THE PADDLE SHIFTED AND THERE WAS MYOPATHY THAT CAUSED THE NEUROLOGICAL DEFICIT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT AFTER THE PERMANENT IMPLANT PROCEDURE, THE PATIENT DEVELOPED A SENSORY MOTOR DEFICIT ON THE LOWER EXTREMITIES. THE PATIENT HAD ALSO EXPERIENCED INCREASED NUMBNESS AND WEAKNESS IN THE FEET AND AS A RESULT HAD FALLEN SEVERAL TIMES. A CT SCAN WAS PERFORMED AND THE RESULTS WERE NORMAL. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ADVANCED IMAGING AND GIVEN STEROID MEDICATION. THE PATIENT WAS SUBSEQUENTLY EXPLANTED AND DECLARED PERMANENTLY PARALYZED FROM THE WAIST DOWN BY THE PHYSICIAN. THE PHYSICIAN STATES IT IS POSSIBLE FOR THE EVENT TO BE DEVICE AND PROCEDURE RELATED AS THE PATIENT'S SYMPTOMS NEVER PROGRESSED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT AFTER THE PERMANENT IMPLANT PROCEDURE, THE PATIENT DEVELOPED A SENSORY MOTOR DEFICIT ON THE LOWER EXTREMITIES. THE PATIENT HAD ALSO EXPERIENCED INCREASED NUMBNESS AND WEAKNESS IN THE FEET AND AS A RESULT HAD FALLEN SEVERAL TIMES. A CT SCAN WAS PERFORMED AND THE RESULTS WERE NORMAL. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ADVANCED IMAGING AND GIVEN STEROID MEDICATION. THE PATIENT WAS SUBSEQUENTLY EXPLANTED AND DECLARED PERMANENTLY PARALYZED FROM THE WAIST DOWN BY THE PHYSICIAN. THE PHYSICIAN STATES IT IS POSSIBLE FOR THE EVENT TO BE DEVICE AND PROCEDURE RELATED AS THE PATIENT'S SYMPTOMS NEVER PROGRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49648 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R