BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME 16

    MDR report key: 14190370 · Received April 22, 2022

    Report

    Report Number
    3006630150-2022-01800
    Event Type
    Injury
    Date Received
    April 22, 2022
    Date of Event
    March 23, 2022
    Report Date
    August 10, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985068
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(4), BATCH: 7073505. PRODUCT FAMILY: SCS-LEAD FIXATION UPN: M365SC43180, MODEL: SC-4318, SERIAL: N/A, BATCH: 28504931.

    Additional Manufacturer Narrative · 0

    WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE EVENT OF THE PATIENT EXPERIENCING AN INFECTION AT THE SPINAL CORD STIMULATION IMPLANTABLE PULSE GENERATOR SITE IS A KNOWN RISK, AS DOCUMENTED IN THE INSTRUCTIONS FOR USE. THE IPG SC-1416 SERIAL NUMBER: (B)(6) WAS RETURNED AND ANALYZED. A VISUAL INSPECTION AND RESIDUAL GAS ANALYSIS FOUND NO ANOMALIES. THE RETURNED LEAD SC-2352-70, SERIAL NUMBER: (B)(6) WAS ANALYZED AND REVEALED THAT THE LEAD WAS CLEANLY CUT INTO TWO PIECES. THE DAMAGE WAS SIMILAR TO THE TYPICAL EXPLANT DAMAGE. VISUAL AND X-RAY INSPECTIONS CONFIRMED THE LEAD HAS NO CABLE FRACTURES. THE RETURNED CLIK X ANCHOR SC-1416, LOT NUMBER: 28504931 WAS ANALYZED AND REVEALED THAT THREE EYELETS WERE JUST TORN WITHOUT MISSING SILICONE MATERIAL. THE DAMAGE TO THE EYELETS IS A TYPICAL EXPLANT PROCEDURE RESULT AND NOT CONSIDERED THE SOURCE OF THE REPORTED PATIENTS EXPERIENCE. A LABELING REVIEW WAS PERFORMED ON THE DEVICES AND DID NOT REVEAL ANY ANOMALIES. THE IFU STATES THAT POSSIBLE SURGICAL PROCEDURAL RISKS ARE TEMPORARY PAIN AT THE IMPLANT SITE, INFECTION, CEREBROSPINAL FLUID CSF LEAKAGE AND, ALTHOUGH RARE, EPIDURAL HEMORRHAGE, SEROMA, HEMATOMA AND PARALYSIS, WHICH ARE A KNOWN RISK OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PATIENT HAD SYMPTOMS OF REDNESS AT THE SITE AND FEVER. THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO INFECTION. THE IPG, LEAD, AND LEAD EXTENSION WERE EXPLANTED. A CULTURE WAS TAKEN, BUT MICROBIOLOGY WAS NEGATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PATIENT HAD SYMPTOMS OF REDNESS AT THE SITE AND FEVER. THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO INFECTION. THE IPG, LEAD, AND LEAD EXTENSION WERE EXPLANTED. A CULTURE WAS TAKEN BUT MICROBIOLOGY WAS NEGATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PATIENT HAD SYMPTOMS OF REDNESS AT THE SITE AND FEVER. THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO INFECTION. THE IPG, LEAD, AND LEAD EXTENSION WERE EXPLANTED. A CULTURE WAS TAKEN BUT MICROBIOLOGY WAS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128059 WAVEWRITER ALPHA PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1416 208387 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention