BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11904871 · Received May 28, 2021

    Report

    Report Number
    3006630150-2021-02500
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    April 30, 2021
    Report Date
    August 6, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7048653. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2352500. MODEL: SC-2352-50. SERIAL: (B)(6). BATCH: 7072673. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2352500. MODEL: SC-2352-50. SERIAL: (B)(6). BATCH: 5141925. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 5140708.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT PRESENTED WITH PAIN AT THE LEAD IMPLANT SITE AT THE LEVEL OF THE SACRAL HIATUS DURING THE POST-IMPLANT VISIT. THE PHYSICIAN ASSESSED THAT THE REPORTED PAIN IS COMMON FOR SACRAL LEADS AND WAS PROBABLY RELATED TO PROCEDURE. HOWEVER, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO CONTINUED EXTREME SENSITIVITY AND FIRMNESS AT THE LEAD IMPLANT SITE, AND UNDERWENT AN EXPLANT PROCEDURE TO REMOVE THE DEVICE. CULTURES WERE TAKEN AND TESTED GRAM POSITIVE. THE DEVICES WERE DISCARDED BY THE FACILITY, AND WERE NOT RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-2218-50, SERIAL/LOT: (B)(4), DESCRIPTION: LINEAR ST LEAD KIT 50 CM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE PHYSICIAN FOR ROUTINE PROGRAMMING FOLLOWING IMPLANTATION OF THE DEVICE. THE PATIENT REPORTED PAIN AT THE IMPLANT SITE. THE PHYSICIAN NOTED THAT THIS IS COMMON FOR SACRAL LEADS. SUBSEQUENTLY THE PATIENT CONTINUED TO HAVE PAIN AND WAS ADMITTED TO THE HOSPITAL. THE PHYSICIAN EXPLANTED THE SYSTEM AND TOOK CULTURES OF THE INFECTED SITE. THE PATIENT WAS GRAM POSITIVE FOR INFECTION AND IS EXPECTED TO FULLY RECOVER FOLLOWING THE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800378 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 376969 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R