BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 8723165 · Received June 21, 2019

    Report

    Report Number
    3004209178-2019-12108
    Event Type
    Injury
    Date Received
    June 21, 2019
    Date of Event
    June 17, 2019
    Report Date
    August 14, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169630512
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8784, SERIAL# (B)(4), IMPLANTED: (B)(6) 2019, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: CATHETER; PRODUCT ID: 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2019, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: CATHETER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8784, SERIAL/LOT #: (B)(4), UBD: 14-MAR-2020, UDI#: (B)(4); PRODUCT ID: 8781, SERIAL/LOT #: (B)(4), UBD: 14-JUL-2020, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE PUMP AND CATHETER WERE RETURNED. ANALYSIS FOUND NO ANOMALY ON THE PUMP. CATHETERS HAD CATHETER/SC CONNECTOR/TEAR IN SEAL NEAR GUIDE RING AND CATHETER/CATHETER BODY/TORN OR BROKEN OR MELTED AT OR AFTER EXPLANT/DID NOT AFFECT INFUSION. 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 PROFESSIONAL (HCP) VIA MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS RECEIVING BACLOFEN, UNKNOWN CONCENTRATION AT UNKNOWN DOSE VIA INTRATHECAL DRUG DELIVERY PUMP FOR INTRACTABLE SPASTICITY. IT WAS REPORTED THAT PATIENT HAD SIGNS/SYMPTOMS OF INFECTION. ANY ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY CONTRIBUTED TO THE ISSUE WERE NOT APPLICABLE. THE HCP HAD DRAINED AND WASHED OUT POCKET IN PAST. SYSTEM WAS REMOVED. AT THE TIME OF THIS REPORT, THE ISSUE HAD RESOLVED AND PATIENT STATUS WAS ALIVE-NO INJURY. THE EXPLANTED DEVICES WOULD BE RETURNED AND THE REP HAD THE POSSESSION OF THE DEVICES. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516701 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169630512

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention