BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 4274941 · Received November 24, 2014

    Report

    Report Number
    3006630150-2014-02739
    Event Type
    Malfunction
    Date Received
    November 24, 2014
    Date of Event
    September 28, 2014
    Report Date
    October 28, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#: SC-8120-70, SERIAL #: (B)(4), DESCRIPTION: ARTISAN 2X8 SURGICAL LEAD - 70 CM.

    Additional Manufacturer Narrative · 1

    SC-1110 (SN (B)(4)) DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT WAS NOT CONFIRMED. DEVICE EXHIBITED NORMAL CHARGING AND DISCHARGING CHARACTERISTICS WHEN CHARGED WITH RECOMMENDED OPTIMAL ALIGNMENT. WHEN ALIGNMENT OPTIMIZATION IS REDUCED, CHARGING COULD LENGTHEN CONSIDERABLY. THE BATTERY WAS DEPLETING ITS CHARGE AT A RATE OF 12 MVDC PER DAY WITH THE STIMULATION TURNED OFF, WHICH WAS WITHIN THE TYPICAL IPG BATTERY DEPLETION RATE. THE COMPLAINT OF HIGH IMPEDANCE WAS NOT CONFIRMED AS VARIOUS TEST LEADS WERE INSERTED IN BOTH PORTS. ALL IMPEDANCE READINGS WERE WITHIN NORMAL RANGE. HIGH IMPEDANCE READINGS COULD NOT BE DUPLICATED IN THE LAB. THE DEVICE EXHIBITED NORMAL DEVICE CHARACTERISTICS. SC-8120-70 (SN (B)(4)) THE COMPLAINT OF HIGH IMPEDANCE ON CONTACT # 6 WAS CONFIRMED. VISUAL (MICROSCOPE) AND X-RAY INSPECTION FOUND FRACTURED CABLES AT THE BENT/KINKED LOCATION OF THE LEAD. IT APPEARED TO BE WHERE THE LEAD BODIES WERE SUTURED. HIGH IMPEDANCE READINGS WERE REGISTERED ON CONTACTS # 1, 6, 7, 8, AND 14. THE LEAD BODY OF RIGHT PIGTAIL SHOWED EXPOSED CABLES AND MINOR CUTS. IN ADDITION, THE PADDLE WAS PARTIALLY TORN RIGHT AT THE JUNCTION OF THE TWO LEAD BODIES. THIS PADDLE DAMAGE WAS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND NOT CONSIDERED A FAILURE. THE HIGH IMPEDANCE COMPLAINT ON CONTACTS # 9 AND 15 WERE NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG AND LEAD REPLACEMENT. THE PHYSICIAN BELIEVED THERE WAS NO MALFUNCTION ON THE IPG AND STATED THAT LEAD TAIL MAY HAVE BEEN DAMAGED WHERE THE SUTURE SLEEVE WAS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING FREQUENT IPG CHARGING. DATABASE ANALYSIS REVEALED HIGH IMPEDANCES ON FEW CONTACTS OF THE LEAD AND THE BATTERY DISCHARGE WAS OBSERVED TO BE WITHIN AN EXPECTED RANGE. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE AND POSSIBLE REPLACEMENT OF THE LEAD.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING FREQUENT IPG CHARGING. DATABASE ANALYSIS REVEALED HIGH IMPEDANCES ON FEW CONTACTS OF THE LEAD AND THE BATTERY DISCHARGE WAS OBSERVED TO BE WITHIN AN EXPECTED RANGE. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE AND POSSIBLE REPLACEMENT OF THE LEAD.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING FREQUENT IPG CHARGING. DATABASE ANALYSIS REVEALED HIGH IMPEDANCES ON FEW CONTACTS OF THE LEAD AND THE BATTERY DISCHARGE WAS OBSERVED TO BE WITHIN AN EXPECTED RANGE. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE AND POSSIBLE REPLACEMENT OF THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760172 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR