BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 12448238 · Received September 9, 2021

    Report

    Report Number
    3006630150-2021-05069
    Event Type
    Injury
    Date Received
    September 9, 2021
    Date of Event
    August 17, 2021
    Report Date
    October 1, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE EXPLANTED SCS SYSTEM WAS DISCARDED. THE PHYSICIAN DID NOT SUSPECT INTEGRITY OF THE SCS SYSTEM. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN DID NOT THINK THAT THE INFECTION WAS RELATED TO THE DEVICE NOR THE SURGERY HAD CAUSED IT. THE PATIENT WAS PLACED ON ANTIBIOTICS.

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 7076663/7080210. PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: M365SC43180, MODEL: SC-4318, SERIAL: N/A, BATCH: 27370037.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE EXPLANTED SCS SYSTEM WAS DISCARDED. THE PHYSICIAN DID NOT SUSPECT THE INTEGRITY OF THE SCS SYSTEM. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343618 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 506588 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention