BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 6031574 · Received October 14, 2016

    Report

    Report Number
    3006630150-2016-02920
    Event Type
    Injury
    Date Received
    October 14, 2016
    Date of Event
    July 2, 2016
    Report Date
    September 17, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING NEW AREAS OF PAIN AND THE REVISION WAS NOT ADDRESS THE POCKET ISSUE. IT WAS NOTED THAT THERE WAS NO SKIN EROSION OR POTENTIAL SIGNS OF EROSION AND EVERYTHING WAS HEALED PERFECTLY NORMAL.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MODEL#: SC-2218-50, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM; MODEL#: SC-1132, SERIAL #: (B)(4), DESCRIPTION:PRECISION SPECTRA IMPLANTABLE PULSE GENERATOR; MODEL#: SC-4316, LOT #: 17894796, DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES 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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT AFTER AN IMPLANT PROCEDURE, THE PATIENT WAS EXPERIENCING INCREASED LOW BACK PAIN AFTER BENDING OVER AND MILD PAIN AT BATTERY INCISION SITE. IT WAS MENTIONED THAT THE PATIENT FELL. THERE WAS EPIDURAL LEAD DAMAGE NOTED DUE TO FALL. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED. NO DEVICE MALFUNCTION SUSPECTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT AFTER AN IMPLANT PROCEDURE, THE PATIENT WAS EXPERIENCING INCREASED LOW BACK PAIN AFTER BENDING OVER AND MILD PAIN AT BATTERY INCISION SITE. IT WAS MENTIONED THAT THE PATIENT FELL. THERE WAS EPIDURAL LEAD DAMAGE NOTED DUE TO FALL. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED. NO DEVICE MALFUNCTION SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680510 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention