BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION SPECTRA

    MDR report key: 6560622 · Received May 11, 2017

    Report

    Report Number
    3006630150-2017-01822
    Event Type
    Malfunction
    Date Received
    May 11, 2017
    Date of Event
    March 23, 2017
    Report Date
    April 18, 2017
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767695
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL # SC-4316 LOT # NI DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE SC-2158-50/3000661: THE COMPLAINT WAS CONFIRMED. SIX CABLES WERE FRACTURED AT THE KINKED SECTIONS OF THE LEAD BODY WHERE A CLIK ANCHORED, BUT NO CABLES WERE EXPOSED AT THE SITE. SC-4316 : THE CLIK ANCHOR REVEALED NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL: SC-4316 SERIAL/LOT: (B)(4) DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING SEX AND NOTICED THEREAFTER THAT THE STIMULATION CHANGED AND WAS NOW INTERMITTENT. IT WAS NOTED THAT THERE WERE HIGH IMPEDANCES ON THE LEAD. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS REPORTEDLY DOING WELL POST-OPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING SEX AND NOTICED THEREAFTER THAT THE STIMULATION CHANGED AND WAS NOW INTERMITTENT. IT WAS NOTED THAT THERE WERE HIGH IMPEDANCES ON THE LEAD. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS REPORTEDLY DOING WELL POST-OPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING SEX AND NOTICED THEREAFTER THAT THE STIMULATION CHANGED AND WAS NOW INTERMITTENT. IT WAS NOTED THAT THERE WERE HIGH IMPEDANCES ON THE LEAD. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS REPORTEDLY DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342952 PRECISION SPECTRA SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2158-50 NA 08714729767695

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR