BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 15611787 · Received October 14, 2022

    Report

    Report Number
    3006630150-2022-05556
    Event Type
    Injury
    Date Received
    October 14, 2022
    Date of Event
    September 20, 2022
    Report Date
    November 23, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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: 7111731. BATCH: 7111731. PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL:(B)(4). BATCH: 7111558.

    Additional Manufacturer Narrative · 0

    CORRECTION TO FIELD H6: IMPACT CODES.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180. MODEL: SC-4318. SERIAL: N/A. BATCH: 29121450.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EIGHT DAYS POST-IMPLANT, THE PATIENT EXPERIENCED SOME PAIN AROUND THE INCISION SITES. THE PATIENT WAS EVALUATED AND AN IMAGE WAS TAKEN OF THE INCISION SITES, WHICH SHOWED EVIDENCE OF IRRITATION AROUND THE STAPLES AND MILD THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP). THE STAPLES WERE REMOVED AND STERI-STRIPS WERE PLACED. THE PATIENT WAS STARTED ON KEFLEX MEDICATION FOR TEN DAYS. THE PATIENT WAS ADVISED TO RETURN AFTER THREE DAYS. THE PATIENT LATER RETURNED FOR ANOTHER EVALUATION AND IT WAS DETERMINED THAT THE SPINAL CORD STIMULATOR (SCS) IMPLANTABLE PULSE GENERATOR (IPG) WOULD BE EXPLANTED THE SAME DAY. ADDITIONALLY, THE LEADS AND CLIK ANCHORS WERE ALSO REMOVED DURING THE EXPLANT PROCEDURE. CULTURE SWABS WERE TAKEN FROM THE PUS COMING OUT OF THE IPG SITE. THE INCISION SITES WERE THEN FLUSHED WITH IRRIGATION AND CLOSED. THE PHYSICIAN ASSESSED THE EVENT AS RESOLVED. THE EVENT WAS ALSO ASSESSED AS HAVING A CAUSAL RELATIONSHIP TO THE PROCEDURE AND TO THE DEVICE HARDWARE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EIGHT DAYS POST-IMPLANT, THE PATIENT EXPERIENCED SOME PAIN AROUND THE INCISION SITES. THE PATIENT WAS EVALUATED AND AN IMAGE WAS TAKEN OF THE INCISION SITES, WHICH SHOWED EVIDENCE OF IRRITATION AROUND THE STAPLES AND MILD THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP). THE STAPLES WERE REMOVED AND STERI-STRIPS WERE PLACED. THE PATIENT WAS STARTED ON KEFLEX MEDICATION FOR TEN DAYS. THE PATIENT WAS ADVISED TO RETURN AFTER THREE DAYS. THE PATIENT LATER RETURNED FOR ANOTHER EVALUATION AND IT WAS DETERMINED THAT THE SPINAL CORD STIMULATOR (SCS) IMPLANTABLE PULSE GENERATOR (IPG) WOULD BE EXPLANTED THE SAME DAY. ADDITIONALLY, THE LEADS AND CLIK ANCHORS WERE ALSO REMOVED DURING THE EXPLANT PROCEDURE. CULTURE SWABS WERE TAKEN FROM THE PUS COMING OUT OF THE IPG SITE. THE INCISION SITES WERE THEN FLUSHED WITH IRRIGATION AND CLOSED. THE PHYSICIAN ASSESSED THE EVENT AS RESOLVED. THE EVENT WAS ALSO ASSESSED AS HAVING A CAUSAL RELATIONSHIP TO THE PROCEDURE AND TO THE DEVICE HARDWARE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EIGHT DAYS POST-IMPLANT, THE PATIENT EXPERIENCED SOME PAIN AROUND THE INCISION SITES. THE PATIENT WAS EVALUATED AND AN IMAGE WAS TAKEN OF THE INCISION SITES, WHICH SHOWED EVIDENCE OF IRRITATION AROUND THE STAPLES AND MILD THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP). THE STAPLES WERE REMOVED AND STERI-STRIPS WERE PLACED. THE PATIENT WAS STARTED ON KEFLEX MEDICATION FOR TEN DAYS. THE PATIENT WAS ADVISED TO RETURN AFTER THREE DAYS. THE PATIENT LATER RETURNED FOR ANOTHER EVALUATION AND IT WAS DETERMINED THAT THE SPINAL CORD STIMULATOR (SCS) IMPLANTABLE PULSE GENERATOR (IPG) WOULD BE EXPLANTED THE SAME DAY. ADDITIONALLY, THE LEADS AND CLIK ANCHORS WERE ALSO REMOVED DURING THE EXPLANT PROCEDURE. CULTURE SWABS WERE TAKEN FROM THE PUS COMING OUT OF THE IPG SITE. THE INCISION SITES WERE THEN FLUSHED WITH IRRIGATION AND CLOSED. THE PHYSICIAN ASSESSED THE EVENT AS RESOLVED. THE EVENT WAS ALSO ASSESSED AS HAVING A CAUSAL RELATIONSHIP TO THE PROCEDURE AND TO THE DEVICE HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2876890 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 540778 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention