BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 4061655 · Received September 4, 2014

    Report

    Report Number
    3006630150-2014-02015
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 1, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN AGREED TO EXPLANT THE PATIENT¿S LEADS OUT FROM THE PATIENT¿S BODY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE FOR THE LEADS THAT WAS LEFT INSIDE THE PATIENT'S BODY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN SUSPECTED DEVICE MALFUNCTION WITH THE LEADS. THE PATIENT WAS NOT RECEIVING THE BENEFIT FROM THE UNIT AND PHYSICIAN OPTED NOT TO HAVE A LEAD REVISION. IT WAS PHYSICIAN¿S PLAN TO LEAVE THE LEADS INSIDE THE PATIENT¿S BODY. NO FURTHER COURSE OF ACTION WILL BE DONE WITH THE LEADS. 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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING SURGES. MULTIPLE CONTACTS ON THE PATIENT¿S LEADS WERE PRODUCING HIGH IMPEDANCES. THE PHYSICIAN SUSPECTED LEAD FRACTURE DUE TO THE HIGH IMPEDANCES AND RECOMMENDED LEAD REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING SURGES. MULTIPLE CONTACTS ON THE PATIENT'S LEADS WERE PRODUCING HIGH IMPEDANCES. THE PHYSICIAN SUSPECTED LEAD FRACTURE DUE TO THE HIGH IMPEDANCES AND RECOMMENDED LEAD REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING SURGES. MULTIPLE CONTACTS ON THE PATIENT'S LEADS WERE PRODUCING HIGH IMPEDANCES. THE PHYSICIAN SUSPECTED LEAD FRACTURE DUE TO THE HIGH IMPEDANCES AND RECOMMENDED LEAD REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING SURGES. MULTIPLE CONTACTS ON THE PATIENT¿S LEADS WERE PRODUCING HIGH IMPEDANCES. THE PHYSICIAN SUSPECTED LEAD FRACTURE DUE TO THE HIGH IMPEDANCES AND RECOMMENDED LEAD REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542071 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention