BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10696811 · Received October 19, 2020

    Report

    Report Number
    3006630150-2020-04955
    Event Type
    Injury
    Date Received
    October 19, 2020
    Date of Event
    September 30, 2020
    Report Date
    November 23, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SC-1160 (B)(6). THE RETURNED IPG WAS ANALYZED, DEVICE HISTORY RECORD REVIEW AND RESIDUAL GAS ANALYSIS FOUND NO ANOMALIES. THE ALLEGATION OF PATIENT HAD AN INFECTION AT THE IPG AND MIDLINE INCISION SITE WAS NOT CONFIRMED. HOWEVER, INFECTION IS ONE OF THE POTENTIAL RISKS OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION BASED ON THE IFU. THEREFORE, THE CONCLUSION CODE KNOWN INHERENT RISK OF DEVICE WILL BE USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD AN INFECTION AT THE IPG AND MIDLINE INCISION SITE. SYMPTOMS WERE REDNESS AND TENDERNESS AT THE INCISION SITES. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE AND PROCEDURE RELATED AND THE CAUSE WAS UNKNOWN. THE PATIENT WAS PLACED AN ANTIBIOTICS. ALL COMPONENTS WERE EXPLANTED AND WILL BE RETURNED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: 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: (B)(4), MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7080446/7080340.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD AN INFECTION AT THE IPG AND MIDLINE INCISION SITE. SYMPTOMS WERE REDNESS AND TENDERNESS AT THE INCISION SITES. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE AND PROCEDURE RELATED AND THE CAUSE WAS UNKNOWN. THE PATIENT WAS PLACED AN ANTIBIOTICS. ALL COMPONENTS WERE EXPLANTED AND WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1162186 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 370101 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention