BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 24892841 · Received April 16, 2026

    Report

    Report Number
    3006630150-2026-02377
    Event Type
    Injury
    Date Received
    April 16, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 4, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    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: BRAND NAME: AVISTA MRI PERC LEAD KIT 56 CM MODEL: SC-2408-56 SERIAL: (B)(6). BATCH: 7087604 UDI: (B)(4). BRAND NAME: AVISTA MRI PERC LEAD KIT 56 CM MODEL: SC-2408-56 SERIAL: (B)(6). BATCH: 7087621 UDI: (B)(4). BRAND NAME: AVISTA MRI PERC LEAD KIT 56 CM MODEL: SC-2408-56 SERIAL: (B)(6). BATCH: 7087609 UDI: (B)(4). BRAND NAME: AVISTA MRI PERC LEAD KIT 56 CM MODEL: SC-2408-56 SERIAL: (B)(6). BATCH: 7087807 UDI: (B)(4). BRAND NAME: CLIK X MRI ANCHOR MODEL: SC-4319 SERIAL: N/A BATCH: 35562807 UDI: (B)(4). BRAND NAME: CLIK X MRI ANCHOR MODEL: SC-4319 SERIAL: N/A BATCH: 35674805 UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: AVISTA MRI PERC LEAD KIT 56 CM MODEL: SC-2408-56 SERIAL: (B)(6) BATCH: 7087604 UDI: (B)(4). BRAND NAME: AVISTA MRI PERC LEAD KIT 56 CM MODEL: SC-2408-56 SERIAL: (B)(6) BATCH: 7087621 UDI: (B)(4). BRAND NAME: AVISTA MRI PERC LEAD KIT 56 CM MODEL: SC-2408-56 SERIAL: (B)(6) BATCH: 7087609 UDI: (B)(4). BRAND NAME: AVISTA MRI PERC LEAD KIT 56 CM MODEL: SC-2408-56 SERIAL: (B)(6) BATCH: 7087807 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT HE EXPERIENCED CONTINUOUS DROOLING AND CLAIMED LEFT FACIAL PARALYSIS. THE PATIENT CONTACTED THE HOSPITAL AND WAS ADVISED TO CONTACT THE PATIENTS PHYSICIAN. THE CAUSAL RELATIONSHIP WITH SPINAL CORD STIMULATION (SCS) IS UNKNOWN; HOWEVER, AS A PRECAUTION, GUIDANCE WAS GIVEN TO REDUCE THE STIMULATION OR TURN OFF THE STIMULATION. THE DEVICES REMAIN IMPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT HE EXPERIENCED CONTINUOUS DROOLING AND CLAIMED LEFT FACIAL PARALYSIS. THE PATIENT CONTACTED THE HOSPITAL AND WAS ADVISED TO CONTACT THEIR PHYSICIAN. THE CAUSAL RELATIONSHIP WITH SPINAL CORD STIMULATION (SCS) IS UNKNOWN; HOWEVER, AS A PRECAUTION, GUIDANCE WAS PROVIDED TO REDUCE STIMULATION FROM THE REMOTE OR TURN OFF THE STIMULATION. THE DEVICES REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462977 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 790883 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1