BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 10564621 · Received September 21, 2020

    Report

    Report Number
    3006630150-2020-04371
    Event Type
    Injury
    Date Received
    September 21, 2020
    Date of Event
    July 13, 2020
    Report Date
    November 18, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: M365SC2408740, MODEL: SC-2408-74, SERIAL: (B)(6), AND BATCH: 7070886. PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: UNK-M-SC-2408-74, MODEL: SC-2408-74, SERIAL: (B)(6), AND BATCH: 7070907. PRODUCT FAMILY: SCS-LEAD FIXATION-MRI, UPN: M365SC43190, MODEL: SC-4319, SERIAL: N/A, AND BATCH: N/A. THE RETURNED IPG AND TWO LEADS WERE ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. UNABLE TO CONFIRM THE AS REPORTED OBSERVATION WITH TESTING OF THE PRODUCT RETURN. HENCE, THE PROBABLE CAUSE SELECTED FOR THIS COMPLAINT IS NO PROBLEM DETECTED. NO ESCALATION IS REQUIRED AT THIS TIME. SC-4319: SILICONE MATERIAL FROM THE EYELETS OF ONE OF THE CLIK ANCHOR WAS MISSING. THE DAMAGE TO THE EYELETS IS A RESULT OF A TYPICAL EXPLANT PROCEDURE, AND IT IS NOT CONSIDERED A FAILURE. THEREFORE, THE PROBABLE CAUSE SELECTED IS NO PROBLEM DETECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED OVERSTIMULATION IN THE PAIN TARGET AREA WHICH WAS CAUSED AT RANDOM TIMES. REPROGRAMMING WAS ATTEMPTED WITHOUT ANY SUCCESS. DATABASE ANALYSIS OF THE DEVICE REVEALED NO ANOMALIES. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE IPG AND TWO LEADS WERE EXPLANTED AND REPLACED. BIPOLAR CAUTERY WAS USED DURING THE REVISION PROCEDURE. PER THE PHYSICIANS IMPLANT MANUAL, ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND WARNS AGAINST THE USE OF ELECTROCAUTERY. THE PATIENT IS DOING WELL POST OPERATIVELY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: (B)(4), MODEL: SC-2408-74, SERIAL: UNKNOWN, BATCH: UNKNOWN. PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: UNK-M-SC-2408-74, MODEL: SC-2408-74, SERIAL: UNKNOWN, BATCH: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED OVERSTIMULATION IN THE PAIN TARGET AREA WHICH WAS CAUSED AT RANDOM TIMES. REPROGRAMMING WAS ATTEMPTED WITHOUT ANY SUCCESS. DATABASE ANALYSIS OF THE DEVICE REVEALED NO ANOMALIES. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE IPG AND TWO LEADS WERE EXPLANTED AND REPLACED. BIPOLAR CAUTERY WAS USED DURING THE REVISION PROCEDURE. PER THE PHYSICIANS IMPLANT MANUAL, ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND WARNS AGAINST THE USE OF ELECTROCAUTERY. THE PATIENT IS DOING WELL POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028914 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 366628 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention