BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10928272 · Received December 1, 2020

    Report

    Report Number
    3006630150-2020-05907
    Event Type
    Injury
    Date Received
    December 1, 2020
    Date of Event
    November 9, 2020
    Report Date
    May 13, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE POCKET SITE AND LEAD INCISION SITE. SYMPTOM OF PAIN TO THE LEFT OF THE PADDLE LEAD AND DRAINAGE FROM THE INCISION SITE WEE NOTED. THE CAUSE OF THE INFECTION WAS UNKNOWN HOWEVER, THE PHYSICIAN NOTED THAT THE PATIENTS LIFESTYLE COULD BE A CONTRIBUTING CAUSE. THE PATIENT WAS PLACED IN IV ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED DEVICES WERE NOT RETURNED. THE PATIENT WAS RECOVERING WELL POSTOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S IPG HAD PREMATURE BATTERY DEPLETION.

    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-PADDLE LEADS, UPN: (B)(4), MODEL: SC-8336-50, SERIAL: (B)(4), BATCH: 7072449.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE POCKET SITE AND LEAD INCISION SITE. SYMPTOM OF PAIN TO THE LEFT OF THE PADDLE LEAD AND DRAINAGE FROM THE INCISION SITE WEE NOTED. THE CAUSE OF THE INFECTION WAS UNKNOWN HOWEVER, THE PHYSICIAN NOTED THAT THE PATIENTS LIFESTYLE COULD BE A CONTRIBUTING CAUSE. THE PATIENT WAS PLACED IN IV ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED DEVICES WERE NOT RETURNED. THE PATIENT WAS RECOVERING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395258 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 371382 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention