BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA®

    MDR report key: 4251874 · Received November 14, 2014

    Report

    Report Number
    3006630150-2014-02599
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2316-70, SERIAL #: (B)(4), DESCRIPTION: INFINION 70 CM LEAD KIT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT REGARDING LEAD SC-2316-70, (SN (B)(4)) WAS CONFIRMED. THE CAUSE OF THE HIGH IMPEDANCES OBSERVED ARE DUE TO SEVERED CABLES IN THE PROXIMAL ARRAY. VISUAL INSPECTION FOUND THAT THE LEAD BODY WAS SEVERELY BENT RIGHT AFTER THE RETENTION SLEEVE. THERE WERE NO EXPOSED CABLES. THE LEAD PASSED MECHANICAL TESTS PERFORMED. THE COMPLAINT REGARDING LEAD SC-2316-70, (SN (B)(4)) WAS CONFIRMED. THE CAUSE OF THE HIGH IMPEDANCES OBSERVED ARE DUE TO SEVERED CABLES IN THE PROXIMAL ARRAY. VISUAL INSPECTION FOUND THAT THE LEAD BODY WAS SEVERELY BENT RIGHT AFTER THE RETENTION SLEEVE. THERE WERE NO EXPOSED CABLES. THE DISTAL ELECTRODES #1-#5 WERE TORN OFF AND NOT RETURNED. IT IS NOT KNOWN IF THE MISSING ELECTRODES WERE LEFT IN THE PATIENT. THE ROOT CAUSE OF THE DISTAL ARRAY DAMAGE IS UNKNOWN. THE LEAD PASSED MECHANICAL TESTS PERFORMED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE RIGHT LEAD DISPLAYED PATHOLOGICALLY LOW IMPEDANCES ON SEVERAL CONTACTS.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT REGARDING LEAD SC-2316-70,(SN (B)(4)) WAS CONFIRMED. THE CAUSE OF THE HIGH IMPEDANCES OBSERVED ARE DUE TO SEVERED CABLES IN THE PROXIMAL ARRAY. VISUAL INSPECTION FOUND THAT THE LEAD BODY WAS SEVERELY BENT RIGHT AFTER THE RETENTION SLEEVE. THERE WERE NO EXPOSED CABLES. THE LEAD PASSED MECHANICAL TESTS PERFORMED. THE COMPLAINT OF LOW IMPEDANCE READINGS WAS NOT CONFIRMED. IMPEDANCE MEASURED IN THE LAB WERE OPEN DUE TO FRACTURED CABLES. THE NON-FRACTURED CABLES HAVE GOOD IMPEDANCE READINGS. THE COMPLAINT REGARDING LEAD SC-2316-70,(SN (B)(4)) WAS CONFIRMED. THE CAUSE OF THE HIGH IMPEDANCES OBSERVED ARE DUE TO SEVERED CABLES IN THE PROXIMAL ARRAY. VISUAL INSPECTION FOUND THAT THE LEAD BODY WAS SEVERELY BENT RIGHT AFTER THE RETENTION SLEEVE. THERE WERE NO EXPOSED CABLES. THE DISTAL ELECTRODES #1-#5 WERE TORN OFF AND NOT RETURNED. THE ROOT CAUSE OF THE DISTAL ARRAY DAMAGE IS UNKNOWN. THE LEAD PASSED MECHANICAL TESTS PERFORMED. THE COMPLAINT OF LOW IMPEDANCE COULDN'T BE CONFIRMED DUE TO THE SEVERE DAMAGE TO THE LEAD.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE MISSING ELECTRODE CONTACTS WERE REMOVED FROM THE PATIENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE DUE TO HIGH IMPEDANCE READINGS. THE PHYSICIAN DOES NOT SUSPECT DEVICE MALFUNCTION. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE DUE TO HIGH IMPEDANCE READINGS. THE PHYSICIAN DOES NOT SUSPECT DEVICE MALFUNCTION. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE DUE TO HIGH IMPEDANCE READINGS. THE PHYSICIAN DOES NOT SUSPECT DEVICE MALFUNCTION. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE DUE TO HIGH IMPEDANCE READINGS. THE PHYSICIAN DOES NOT SUSPECT DEVICE MALFUNCTION. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE DUE TO HIGH IMPEDANCE READINGS. THE PHYSICIAN DOES NOT SUSPECT DEVICE MALFUNCTION. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736703 SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention