BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 8971708 · Received September 6, 2019

    Report

    Report Number
    3007566237-2019-01912
    Event Type
    Injury
    Date Received
    September 6, 2019
    Date of Event
    May 6, 2019
    Report Date
    September 6, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT RECEIVING INTRATHECAL LIORESAL 1200 MCG/ML VIA AN IMPLANTED PUMP AND THE INDICATION WAS GENETIC TORSION DYSTONIA. IT WAS REPORTED THE PATIENT¿S WEIGHT WAS (B)(6) AND HEIGHT WAS 62 INCHES. IT WAS REPORTED THE PATIENT WAS SCHEDULED FOR RIGHT KNEE SURGERY ON (B)(6) 2019 FOR AN UNSPECIFIED REASON. IT WAS ALSO REPORTED THE PATIENT HAD BACLOFEN WITHDRAWAL AFTER HER PUMP MOVED AND THE INTRATHECAL CATHETER BECAME TWISTED. IT WAS REPORTED IT STARTED (B)(6) 2019. THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR) AND UNDERWENT REPAIR OF CATHETER WITH RESOLUTION OF SYMPTOMS. THE PATIENT¿S MEDICAL HISTORY INCLUDED GENETIC TORSION DYSTONIA. THE PATIENT¿S DATE OF ADMISSION WAS (B)(6) 2019 TO (B)(6) 2019 AND THE ADMITTING DIAGNOSIS WAS MECHANICAL COMPLICATIONS OF INTRATHECAL CATHETER. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED OR EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765865 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention