BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 7358328 · Received March 21, 2018

    Report

    Report Number
    3006630150-2018-00906
    Event Type
    Injury
    Date Received
    March 21, 2018
    Date of Event
    March 1, 2018
    Report Date
    April 21, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2138500; MODEL: SC-2138-50; SERIAL: (B)(6); BATCH: 103168/103551.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS IPG WOULD NO LONGER CHARGE. THE PATIENT UNDERWENT REVISION PROCEDURE WHEREIN THE IPG WAS REPLACED AND THE LEADS WERE EXPLANTED. NO DEVICE MALFUNCTION WAS SUSPECTED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER COURSE OF ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENTS IPG WAS NO LONGER CHARGING. THE IPG WILL BE REPLACED PER PHYSICIANS PREFERENCE. NO DEVICE MALFUNCTION SUSPECTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE FOR AN UNKNOWN REASON.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE FOR AN UNKNOWN REASON.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE FOR AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200603 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 11644

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention