BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2830922 · Received November 13, 2012

    Report

    Report Number
    3007566237-2012-02703
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Report Date
    April 1, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PUMP WAS EXPLANTED ON (B)(6)-2012.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER INDICATED THE PATIENT¿S PREVIOUS BACLOFEN PUMP WAS ON A RECALL LIST, AND THE PATIENT HAD ALMOST DIED BEFORE THE PUMP WAS REPLACED. THE PATIENT HAD KNOWN SOMETHING ¿WASN¿T RIGHT WITH THE PUMP¿. ADDITIONAL SYMPTOMS HAD INCLUDED INCREASED SPASTICITY; THE PATIENT DIDN¿T HAVE CONTROL. THE DATE OF ONSET WAS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A RETURN OF SYMPTOMS GRADUALLY OVER THE PAST 2-3 MONTHS. THE SYMPTOMS INCLUDED INCREASED BASELINE PAIN AND SPASM. IT WAS STATED THAT THE PATIENT HAD A "BUNCH OF PAIN AND KNOTTING UP." IT WAS INDICATED THAT THE PATIENT WAS TAKING "A LOT" OF ORAL BACLOFEN AS A SUPPLEMENT. THE PATIENT'S LAST REFILL WAS AROUND (B)(6) 2012 AND NEXT REFILL WAS SCHEDULED FOR (B)(6) 2012. THE PUMP WAS EXPLANTED. IT WAS LATER INDICATED THAT PUMP REPLACEMENT OCCURRED DUE TO A PUMP RECALL PER THE PATIENT AND FAMILY. THERE WERE NO PATIENT SIGNS OR SYMPTOMS REPORTED AND NO INJURY. THE DRUGS DELIVERED VIA PUMP WERE MORPHINE AND BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00027 YR Required Intervention