BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 9510440 · Received December 23, 2019

    Report

    Report Number
    3006630150-2019-07601
    Event Type
    Injury
    Date Received
    December 23, 2019
    Date of Event
    December 5, 2015
    Report Date
    December 23, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767688
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE (B)(6) 2015 WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. EXPLANT DATE; 2015. MODEL NUMBER/ CATALOG NUMBER: SC-2208-50, SERIAL NUMBER: (B)(4), BATCH/ LOT NUMBER: 178565, MODEL/ CATALOG DESCRIPTION: ST LINEAR LEAD 50 CM. MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/ LOT NUMBER: 231791, MODEL/ CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT 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 AN EXPLANT PROCEDURE FOR AN UNKNOWN REASON. NO DEVICE MALFUNCTION WAS SUSPECTED. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1304686 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 187423 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention