BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 21340185 · Received February 8, 2025

    Report

    Report Number
    3006630150-2025-00565
    Event Type
    Injury
    Date Received
    February 8, 2025
    Date of Event
    January 15, 2025
    Report Date
    April 28, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT PRODUCT FAMILY: SCS-LEAD FIXATION-MRI UPN: M365SC43190 MODEL: SC-4319 SERIAL: NULL BATCH: 32163844. PRODUCT FAMILY: SCS-LINEAR LEADS-MRI UPN: M365SC2408560 MODEL: SC-2408-56 SERIAL: (B)(6) BATCH: 7082400. PRODUCT FAMILY: SCS-LINEAR LEADS-MRI UPN: M365SC2408560 MODEL: SC-2408-56 SERIAL: (B)(6) BATCH: 7082401.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT. PRODUCT FAMILY: SCS-LEAD FIXATION-MRI. UPN: M365SC43190. MODEL: SC-4319. SERIAL: NULL. BATCH: 32163844. PRODUCT FAMILY: SCS-LINEAR LEADS-MRI. UPN: M365SC2408560. MODEL: SC-2408-56. SERIAL: (B)(6). BATCH: 7082400. PRODUCT FAMILY: SCS-LINEAR LEADS-MRI. UPN: M365SC2408560. MODEL: SC-2408-56. SERIAL: (B)(6). BATCH: 7082401. THERE WAS NO ALLEGATION AGAINST THE FUNCTIONALITY OF THE DEVICE, THE IPG PASSED VISUAL INSPECTION. A LABELING REVIEW WAS PERFORMED ON THE IMPLANTABLE PULSE GENERATOR, IPG, AND LEADS INSTRUCTIONS FOR USE, IFU. THERE WAS NO EVIDENCE THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELED INDICATIONS. IT STATES THE POSSIBLE RISKS OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION INCLUDE SKIN EROSION AT THE IPG SITE AND INFECTION CAN OCCUR OVER TIME. BASED ON ALL AVAILABLE INFORMATION, ENGINEERS ARE ABLE TO CONFIRM THE ROOT CAUSE OF THE EVENT. THE IPG WAS RETURNED AND PASSED VISUAL INSPECTION, THE REST OF THE DEVICES WERE DISCARDED BY THE FACILITY, RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. THEREFORE, THIS INVESTIGATION IS ABLE TO DETERMINE A PROBABLE ROOT CAUSE FOR THE COMPLAINT AND THE CONCLUSION AND INVESTIGATION IS ASSIGNED A PROBABLE CAUSE OF KNOWN INHERENT RISK OF DEVICE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT PRODUCT FAMILY: SCS-LEAD FIXATION-MRI. UPN: M365SC43190. MODEL: SC-4319. SERIAL: NULL. BATCH: 32163844. UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS-MRI. UPN: M365SC2408560. MODEL: SC-2408-56. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS-MRI. UPN: M365SC2408560. MODEL: SC-2408-56. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4). THERE WAS NO ALLEGATION AGAINST THE FUNCTIONALITY OF THE DEVICE, THE IPG PASSED VISUAL INSPECTION. A LABELING REVIEW WAS PERFORMED ON THE IMPLANTABLE PULSE GENERATOR, IPG, AND LEADS INSTRUCTIONS FOR USE, IFU. THERE WAS NO EVIDENCE THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELED INDICATIONS. IT STATES THE POSSIBLE RISKS OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION INCLUDE SKIN EROSION AT THE IPG SITE AND INFECTION CAN OCCUR OVER TIME. BASED ON ALL AVAILABLE INFORMATION, ENGINEERS ARE ABLE TO CONFIRM THE ROOT CAUSE OF THE EVENT. THE IPG WAS RETURNED AND PASSED VISUAL INSPECTION, THE REST OF THE DEVICES WERE DISCARDED BY THE FACILITY, RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. THEREFORE, THIS INVESTIGATION IS ABLE TO DETERMINE A PROBABLE ROOT CAUSE FOR THE COMPLAINT AND THE CONCLUSION AND INVESTIGATION IS ASSIGNED A PROBABLE CAUSE OF KNOWN INHERENT RISK OF DEVICE. CORRECTION TO BLOCK H6.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SIGNS OF EROSION AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE WITH SIGNS OF INFECTION AT IT AND THE LEAD SITE. THE PATIENT STATED FEELING DISCOMFORT A THE IPG SITE FOR SEVERAL MONTHS, AND PAIN ONCE THE EROSION OCCURRED, THERE WERE ALSO REDNESS AND PUSS DISCHARGE FROM THE IPG POCKET SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THE ENTIRE SYSTEM AND WAS PRESCRIBED ANTIBIOTICS. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE FACILITY AT THE PHYSICIANS' DISCRETION DUE TO THE INFECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SIGNS OF EROSION AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE WITH SIGNS OF INFECTION AT IT AND THE LEAD SITE. THE PATIENT STATED FEELING DISCOMFORT A THE IPG SITE FOR SEVERAL MONTHS, AND PAIN ONCE THE EROSION OCCURRED, THERE WERE ALSO REDNESS AND PUSS DISCHARGE FROM THE IPG POCKET SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THE ENTIRE SYSTEM AND WAS PRESCRIBED ANTIBIOTICS. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE FACILITY AT THE PHYSICIANS' DISCRETION DUE TO THE INFECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SIGNS OF EROSION AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE WITH SIGNS OF INFECTION AT IT AND THE LEAD SITE. THE PATIENT STARTED FEELING DISCOMFORT AT THE IPG SITE FOR SEVERAL MONTHS, AND PAIN ONCE THE EROSION OCCURRED, THERE WERE ALSO REDNESS AND PUSS DISCHARGE FROM THE IPG POCKET SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THE ENTIRE SYSTEM, AND WAS PRESCRIBED ANTIBIOTICS. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE FACILITY AT THE PHYSICIANS' DISCRETION DUE TO THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436096 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 587133 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1