BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 6224262 · Received January 4, 2017

    Report

    Report Number
    3006630150-2017-00045
    Event Type
    Injury
    Date Received
    January 4, 2017
    Date of Event
    December 1, 2016
    Report Date
    December 1, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797814
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: MODEL#: SC-2136-50, SERIAL/LOT#: (B)(4), DESCRIPTION: INFINION 1X16 PERC LEAD KIT-50CM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#: SC-3400-30 SERIAL/LOT#: (B)(4) DESCRIPTION: INFINION SPLITTER 2X8 KIT (30 CM) MODEL: SC-4316 SERIAL/LOT#: (B)(4) DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE THE EXPLANTED SPLITTERS WILL NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Additional Manufacturer Narrative · 1

    CORRECTION TO F/U 1 MDR IN FIELD: SHOULD HAVE BEEN CHECKED YES WITH RETURN DATE OF 13JAN2017 SC-2316-50, S/N (B)(4): THE COMPLAINT WAS CONFIRMED. A CONTINUITY TEST SHOWED THAT 12 CONTACTS WERE OPEN. THE SETSCREW WAS LOGGED DOWN BETWEEN CONTACT #15 AND #16. THIS DAMAGE SUGGESTS INCOMPLETE INSERTION OF THE LEAD INTO THE SPLITTER. THE CABLES WERE FRACTURED IN THE PROXIMAL ARRAY, AND ALSO SEVERAL CABLES WERE EXPOSED AT THE PROXIMAL TIP. IN ADDITION, THE PROXIMAL TIP WAS HEAVILY COATED WITH BLOOD STAIN. THE INCOMPLETE LEAD INSERTION AND DAMAGE TO THE PROXIMAL END RESULTED IN THE REPORTED COMPLAINT OF HIGH IMPEDANCE. REVIEW OF THE STERILIZATION RECORDS REVEALED NO ANOMALIES. THE PHYSICIAN ASSESSED THAT THE CABLES WERE EXPOSED DURING THE EXPLANT PROCEDURE, AND NOT PRIOR TO THE EXPLANT PROCEDURE. SC-2316-50, S/N (B)(4): THE COMPLAINT WAS CONFIRMED. A CONTINUITY TEST SHOWED THAT 3 CONTACTS WERE OPEN. THE SETSCREW WAS TIGHTENED ON CONTACT #16. THIS DAMAGE SUGGESTS INCOMPLETE INSERTION OF THE LEAD INTO THE SPLITTER. THE CABLES WERE FRACTURED IN THE PROXIMAL ARRAY, BUT THE CABLES WERE NOT EXPOSED. THE INCOMPLETE LEAD INSERTION AND DAMAGE TO THE PROXIMAL END RESULTED IN THE REPORTED COMPLAINT OF HIGH IMPEDANCE. REVIEW OF THE STERILIZATION RECORDS REVEALED NO ANOMALIES. SC-4316, LOT 18798167: BOTH CLIK ANCHORS HAVE DAMAGED EYELET, AND THE PART OF SILICON MATERIAL FORM THE DAMAGED EYELETS WERE MISSING. REVIEW OF THE STERILIZATION RECORDS REVEALED NO ANOMALIES. THE PHYSICIAN CONFIRMED THAT THE MISSING SILICONE WAS REMOVED FROM THE PATIENT. IT IS INDICATED THAT THE LEAD SPLITTERS WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE 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 THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE DUE TO HIGH IMPEDANCES ON THE LEAD. DURING THE PROCEDURE, THE PHYSICIAN SUSPECTED THE PATIENT HAD A POTENTIAL INFECTION AND ALSO REMOVED THE LEAD SPLITTERS. AN INFECTION WAS SUSPECTED DUE TO THE VISCOSE FLUID IN THE AREA AND BECAUSE IT SMELLED RARE. THE PHYSICIAN ASSESSED THAT THE POSSIBLE INFECTION COULD BE DUE TO THE BIOLFILM IN THE DEVICE. THE PATIENT WAS ADMINISTERED ANTIBIOTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE DUE TO HIGH IMPEDANCES ON THE LEAD. DURING THE PROCEDURE, THE PHYSICIAN SUSPECTED THE PATIENT HAD A POTENTIAL INFECTION AND ALSO REMOVED THE LEAD SPLITTERS. AN INFECTION WAS SUSPECTED DUE TO THE VISCOSE FLUID IN THE AREA AND BECAUSE IT SMELLED RARE. THE PHYSICIAN ASSESSED THAT THE POSSIBLE INFECTION COULD BE DUE TO THE BIOLFILM IN THE DEVICE. THE PATIENT WAS ADMINISTERED ANTIBIOTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE DUE TO HIGH IMPEDANCES ON THE LEAD. DURING THE PROCEDURE, THE PHYSICIAN SUSPECTED THE PATIENT HAD A POTENTIAL INFECTION AND ALSO REMOVED THE LEAD SPLITTERS. AN INFECTION WAS SUSPECTED DUE TO THE VISCOSE FLUID IN THE AREA AND BECAUSE IT SMELLED RARE. THE PHYSICIAN ASSESSED THAT THE POSSIBLE INFECTION COULD BE DUE TO THE BIOLFILM IN THE DEVICE. THE PATIENT WAS ADMINISTERED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7070 PRECISION SPECTRA SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50 N/A 08714729797814

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly| R