BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1614609 · Received February 15, 2010

    Report

    Report Number
    3004209178-2010-01172
    Event Type
    Injury
    Date Received
    February 15, 2010
    Report Date
    January 21, 2010
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Additional Manufacturer Narrative · 1

    ALL PREVIOUSLY REPORTED PATIENT AND DEVICE CODES WILL BE UPDATED/CORRECTED TO THE FOLLOWING FOR THIS EVENT: (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE CATHETER, PRODUCT ID 8590-9, LOT# N222211, IMPLANTED:2009-(B)(6), PRODUCT TYPE ACCESSORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SECOND CATHETER REVISION WAS DONE DUE TO A CONFIRMED CATHETER DISLODGEMENT. SEE MANUFACTURER'S REPORT #3004209178-2010-01155 FOR THE PATIENT'S FIRST CATHETER REVISION. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS PREVIOUSLY INDICATED THAT A SECOND CATHETER REVISION WAS DONE, HOWEVER, ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD CATHETER REVISION DONE ONCE ONLY WITH THE FIRST CATHETER DISLODGEMENT. [SEE MANUFACTURER REPORT# 3004209178-2010-01155]. IT WAS INDICATED WITHIN 2 WEEKS OR LESS AFTER THE REVISION, THE CATHETER "FELL DOWN" AGAIN. IT WAS STATED THAT THE CATHETER WAS CURRENTLY "CURLED UP IN HER SPINE". THE DRUG DELIVERED VIA PUMP WAS SALINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT A MAGNETIC RESONANCE IMAGING OR XRAY OR COMPUTATION TOMOGRAPHY WAS DONE BUT THE RESULT WAS NOT REPORTED. THE PATIENT EXPERIENCED REBOUND SPASTICITY. IT WAS CONFIRMED THAT THE CATHETER MIGRATED TWICE BUT ONLY ONE REVISION WAS DONE. [SEE MANUFACTURER REPORT# 3004209178-2010-01155 FOR FIRST CATHETER MIGRATION AND CATHETER REVISION.] THE PATIENT OUTCOME WAS NOTED AS 'NO INJURY.' THE PUMP WAS BEING USED TO DELIVER LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention EXPLANTED:| CATHETER: MODEL 8709SC, LOT# UNK| PROGRAMMER: MODEL 8840, LOT# UNK| IMPLANTED: