BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 21521357 · Received March 4, 2025

    Report

    Report Number
    3006630150-2025-01221
    Event Type
    Injury
    Date Received
    March 4, 2025
    Date of Event
    January 11, 2025
    Report Date
    April 29, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3 AND D6B DATES ARE APPROXIMATED. GOOD FAITH EFFORTS WERE MADE TO OBTAIN THE INFORMATION; HOWEVER, THE EXACT DATES WERE UNABLE TO BE CONFIRMED. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. BRAND NAME: COVEREDGE 32. UPN: M365SC8336500. MODEL: SC-8336-50. SERIAL: (B)(6). LOT: 7072710. CORRECTION TO THE INITIAL MDR IN BLOCKS; B1: ADVERSE EVENT SHOULD HAVE BEEN SELECTED G2: ONLY COMPANY REPRESENTATIVE AND CONSUMER SHOULD HAVE BEEN SELECTED.

    Additional Manufacturer Narrative · 0

    CORRECTION TO BLOCKS E1, H11. BLOCK B3 AND D6B DATES ARE APPROXIMATED. GOOD FAITH EFFORTS WERE MADE TO OBTAIN THE INFORMATION, HOWEVER, THE EXACT DATES WERE UNABLE TO BE CONFIRMED. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-8336-50. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: (B)(6). MODEL/CATALOG DESCRIPTION: COVEREDGE 32 SURGICAL LEAD KIT 50 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK B3 AND D6B DATES ARE APPROXIMATED. GOOD FAITH EFFORTS WERE MADE TO OBTAIN THE INFORMATION, HOWEVER, THE EXACT DATES WERE UNABLE TO BE CONFIRMED. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, BRAND NAME: COVEREDGE 32, UPN: M365SC8336500, MODEL: SC-8336-50, SERIAL/LOT: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT SHE AWOKE ONE DAY AND WAS UNABLE TO WALK. THE PATIENT STATED THAT THE EXPLANTING PHYSICIAN TOLD HER THAT THE SPINAL CORD STIMULATION DEVICE WAS NOT IMPLANTED CORRECTLY. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE THE SPINAL CORD STIMULATION IMPLANTABLE PULSE GENERATOR AND PADDLE LEAD WERE REMOVED. THE PATIENT REGAINED FEELING IN HER LEGS FOLLOWING THE PROCEDURE. FURTHER INFORMATION REGARDING THE EVENT AND DATES WAS UNABLE TO BE OBTAINED DESPITE THREE GOOD-FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT SHE AWOKE ONE DAY AND WAS UNABLE TO WALK. THE PATIENT STATED THAT THE EXPLANTING PHYSICIAN TOLD HER THAT THE SPINAL CORD STIMULATION DEVICE WAS NOT IMPLANTED CORRECTLY. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE THE SPINAL CORD STIMULATION IMPLANTABLE PULSE GENERATOR AND PADDLE LEAD WERE REMOVED. THE PATIENT REGAINED FEELING IN HER LEGS FOLLOWING THE PROCEDURE. FURTHER INFORMATION REGARDING THE EVENT AND DATES WAS UNABLE TO BE OBTAINED DESPITE THREE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT SHE AWOKE ONE DAY AND WAS UNABLE TO WALK. THE PATIENT STATED THAT THE EXPLANTING PHYSICIAN TOLD HER THAT THE SPINAL CORD STIMULATION DEVICE WAS NOT IMPLANTED CORRECTLY. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE THE SPINAL CORD STIMULATION IMPLANTABLE PULSE GENERATOR AND PADDLE LEAD WERE REMOVED. THE PATIENT REGAINED FEELING IN HER LEGS FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287407 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 502262 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention| O