BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 5995432 · Received October 3, 2016

    Report

    Report Number
    3006630150-2016-02796
    Event Type
    Injury
    Date Received
    October 3, 2016
    Date of Event
    July 19, 2016
    Report Date
    July 19, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    THE RETURNED IPG SC- 1110 (SN(B)(4)) WAS ANALYZED AND NO ANOMALIES WERE FOUND. SC-8120-70 (SN(B)(4)) DEVICE EVALUATION INDICATED THAT THE COMPLAINT OF HIGH IMPEDANCE WAS CONFIRMED. ALTHOUGH THE PADDLE LEAD WAS RETURNED IN PIECES, MOST CABLES WERE FRACTURED AT THE SUTURE SITES. SOME CABLES WERE PULLED AND EXPOSED. THE PULLED AND EXPOSED CABLE DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE. SC-8120-70 (SN: (B)(4)) THE COMPLAINT OF HIGH IMPEDANCE WAS CONFIRMED. ALTHOUGH THE PADDLE LEAD WAS RETURNED IN PIECES, MOST CABLES WERE FRACTURED AT THE SUTURE SITES. SOME CABLES WERE PULLED AND EXPOSED. THE PULLED AND EXPOSED CABLE DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-8120-70 SERIAL #: (B)(4)DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE POCKET SITE. IT WAS ALSO REPORTED THAT THE PATIENT HAD A LOSS OF STIMULATION DUE TO HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN IT WAS DISCOVERED THAT THE LEAD TAIL WAS COMPLETELY REMOVED FROM THE PADDLE PRIOR TO REVISION. THE LEAD AND THE IPG WAS REPLACED. MALFUNCTION WAS SUSPECTED WITH THE LEAD. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE POCKET SITE. IT WAS ALSO REPORTED THAT THE PATIENT HAD A LOSS OF STIMULATION DUE TO HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN IT WAS DISCOVERED THAT THE LEAD TAIL WAS COMPLETELY REMOVED FROM THE PADDLE PRIOR TO REVISION. THE LEAD AND THE IPG WAS REPLACED. MALFUNCTION WAS SUSPECTED WITH THE LEAD. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE POCKET SITE. IT WAS ALSO REPORTED THAT THE PATIENT HAD A LOSS OF STIMULATION DUE TO HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN IT WAS DISCOVERED THAT THE LEAD TAIL WAS COMPLETELY REMOVED FROM THE PADDLE PRIOR TO REVISION. THE LEAD AND THE IPG WAS REPLACED. MALFUNCTION WAS SUSPECTED WITH THE LEAD. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646087 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention