BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 8294683 · Received January 31, 2019

    Report

    Report Number
    3006630150-2019-00322
    Event Type
    Injury
    Date Received
    January 31, 2019
    Date of Event
    January 11, 2019
    Report Date
    May 9, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS FOR SC-1132 S/N (B)(4) - THE DEVICE WAS EVALUATED FOR A POSSIBLE MALFUNCTION AGAINST THE REPORTED EVENT. RESIDUAL GAS ANALYSIS VERIFIED NO LOSS OF ELECTRIC CURRENT INTO THE SURROUNDING TISSUE BECAUSE OF FAULTY INSULATION. REVIEW OF THE STERILIZATION RECORD DID NOT FIND ANY ANOMALIES OR DEVIATIONS THAT POTENTIALLY RELATE TO THE REPORTED EVENT. ANALYSIS FOR SC-2218-70 S/N (B)(4) - A VISUAL INSPECTION FOUND THE LEAD WAS CLEANLY CUT DURING THE EXPLANT. THE DISTAL END WAS NOT RETURNED. THE DEVICE DAMAGE WAS SIMILAR TO THE TYPICAL EXPLANT DAMAGE AND WAS NOT CONSIDERED A FAILURE. REVIEW OF THE STERILIZATION RECORD DID NOT FIND ANY ANOMALIES OR DEVIATIONS THAT POTENTIALLY RELATE TO THE REPORTED EVENT. ANALYSIS FOR SC-2218-70 S/N (B)(4) - A VISUAL INSPECTION FOUND THE LEAD WAS CLEANLY CUT DURING THE EXPLANT. THE DISTAL END WAS NOT RETURNED. THE DEVICE DAMAGE WAS SIMILAR TO THE TYPICAL EXPLANT DAMAGE AND WAS NOT CONSIDERED A FAILURE. REVIEW OF THE STERILIZATION RECORD DID NOT FIND ANY ANOMALIES OR DEVIATIONS THAT POTENTIALLY RELATE TO THE REPORTED EVENT. ANALYSIS FOR SC-4316 LOT # 22203392 - AS THE DEVICE INVOLVED IN THE COMPLAINT HAS NOT BEEN RETURNED, THE COMPLAINT INVESTIGATION SITE (CIS) COULD NOT PERFORM A DEVICE ANALYSIS. HOWEVER, A REVIEW OF THE COMPLAINT REPORT AND STERILIZATION RECORD WERE FOUND TO BE SATISFACTORY AND DID NOT FIND ANY ANOMALIES OR DEVIATIONS THAT POTENTIALLY RELATE TO THE REPORTED EVENT; THERE IS NO REASON TO SUSPECT A MANUFACTURING DEFECT AS THE SOURCE OF THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT A PATIENT EXPERIENCED AN INFECTION AT THE IPG SITE AND HAD THE ENTIRE SCS SYSTEM REMOVED. THE PATIENT WAS PLACED ON ANTIBIOTICS. THE INFECTION WAS NOT CAUSED BY THE DEVICE OR IMPLANT PROCEDURE. THE CAUSE OF THE INFECTION IS NOT KNOWN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: REFERENCE NUMBER: (B)(4), PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: (B)(4), MODEL: SC-4316, BATCH: 22203392.REFERENCE NUMBER: (B)(4) PRODUCT FAMILY: SCS-LINEAR LEADS UPN:(B)(4), MODEL: SC-2218-70 SERIAL: 5073336 BATCH: 5073336. REFERENCE NUMBER: (B)(4), PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-70, SERIAL:(B)(4), BATCH: 5073341.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT EXPERIENCED AN INFECTION AT THE IPG SITE AND HAD THE ENTIRE SCS SYSTEM REMOVED. THE PATIENT WAS PLACED ON ANTIBIOTICS. THE INFECTION WAS NOT CAUSED BY THE DEVICE OR IMPLANT PROCEDURE. THE CAUSE OF THE INFECTION IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88243 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 203766 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention