BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5112153 · Received September 29, 2015

    Report

    Report Number
    3004209178-2015-18953
    Event Type
    Injury
    Date Received
    September 29, 2015
    Report Date
    September 2, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8578, LOT# N153694, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8578, LOT# N153694, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709, LOT# L36861, IMPLANTED: (B)(6) 1996, PRODUCT TYPE: CATHETER. (B)(4)

    Additional Manufacturer Narrative · 1

    CORRECTION: "DATE RECVD BY MFR": FOR THE FOLLOW-UP REPORT SENT EARLIER TODAY IS BEING CORRECTED FROM 2015-12-05 TO 2015-12-04.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A COMPANY REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING BACLOFEN 2000 MCG/ML (DOSE 1181.5 MCG/DAY) VIA AN IMPLANTED PUMP. THE PUMP'S INDICATION FOR USE (IFU) WAS LISTED AS INTRACTABLE SPASTICITY AND SPINAL CORD INJURY/SPINAL CORD DISEASE. A VOLUME DISCREPANCY WAS REPORTED. THE ACTUAL RESIDUAL VOLUME (ARV) WAS ZERO MILLILITERS (MLS) AND THE EXPECTED RESIDUAL VOLUME (ERV) WAS 6.4 MLS. BOTH THE PUMP AND CATHETER WERE REPLACED ON (B)(6) 2015 AND THE PUMP AND CATHETER CONNECTOR PIECE WERE SENT BACK FOR ANALYSIS. PATIENT SYMPTOMS WERE NOT REPORTED. ON (B)(6) 2015, ADDITIONAL INFORMATION WAS RECEIVED FROM A REP INDICATED HE WAS MADE AWARE OF THE POSSIBLE DISCREPANCY DURING THE REPLACEMENT PROCEDURE BY THE HEALTHCARE PROVIDER (HCP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643279 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention