BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 13087589 · Received December 27, 2021

    Report

    Report Number
    3006630150-2021-07162
    Event Type
    Injury
    Date Received
    December 27, 2021
    Date of Event
    November 30, 2021
    Report Date
    May 10, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(4), BATCH: 7071222. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(4), BATCH: 7071148.

    Additional Manufacturer Narrative · 0

    CORRECTION TO INITIAL MDR IN BLOCK B2. CORRECTION TO INITIAL MDR IN H10: BLOCK B3 APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ANALYSIS OF THE RETURNED IPG SC-1216 (SERIAL NUMBER (B)(6)) REVEALED THAT IT WAS UNDETECTABLE AND NOT CHARGED. AN INTERNAL ELECTRICAL INVESTIGATION FOUND THE BATTERY DEPLETED, EXCESSIVE QUIESCENT CURRENT LEAKAGE, AND EXCESSIVE THERMAL TEMPERATURE ON THE APPLICATION-SPECIFIC INTEGRATED CIRCUIT. ATTEMPTS TO RETRIEVE THE DEVICE DATA USING AN EXTERNAL POWER SOURCE WERE UNSUCCESSFUL. THE EXPLANTED LEADS SC-2352-70 (SERIAL NUMBERS (B)(6)) WERE NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG AND LEADS REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A LABELLING REVIEW WAS PERFORMED AND DID NOT REVEAL ANY ANOMALIES. THE INSTRUCTIONS FOR USE (IFU) CAUTIONS THAT THE USE OF ELECTROCAUTERY AS IT MAY DAMAGE THE STIMULATOR. THE PHYSICIAN MENTIONS IN THE COMPLAINT THE USE OF A PLASMA BLADE WHICH MAY HAVE DAMAGED THE IPG. EXPOSURE TO HIGH-VOLTAGE TRANSIENTS OR HIGH RADIO FREQUENCY ENERGY CAN CAUSE THIS TYPE OF IPG DAMAGE; THUS, UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS EXPERIENCING DIFFICULTY CHARGING AND COMMUNICATING WITH THE IMPLANTABLE PULSE GENERATOR (IPG) FOLLOWING A NON-DEVICE RELATED PROCEDURE. AFTER THE PROCEDURE, THE BATTERY WAS THOUGHT TO BE DEPLETED BUT AFTER SEVERAL HOURS OF CHARGING AND USE OF A MAGNET TO TRIGGER PAIRING MODE THE IPG REMAINED UNRESPONSIVE. THE PHYSICIAN BELIEVED THAT ONE OF THE LEADS MADE CONTACT WITH THE PLASMABLADE AND AS A RESULT THE IPG WAS DAMAGED DURING THE PROCEDURE. THE PATIENT UNDERWENT A REPLACEMENT PROCEDURE AND WAS DOING WELL POST-OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS EXPERIENCING DIFFICULTY CHARGING AND COMMUNICATING WITH THE IMPLANTABLE PULSE GENERATOR (IPG) FOLLOWING A NON-DEVICE RELATED PROCEDURE. AFTER THE PROCEDURE, THE BATTERY WAS THOUGHT TO BE DEPLETED BUT AFTER SEVERAL HOURS OF CHARGING AND USE OF A MAGNET TO TRIGGER PAIRING MODE THE IPG REMAINED UNRESPONSIVE. THE PHYSICIAN BELIEVED THAT ONE OF THE LEADS MADE CONTACT WITH THE PLASMABLADE AND AS A RESULT THE IPG WAS DAMAGED DURING THE PROCEDURE. THE PATIENT UNDERWENT A REPLACEMENT PROCEDURE AND WAS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1986510 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 501885 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R