BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2874618 · Received December 15, 2012

    Report

    Report Number
    3007566237-2012-03027
    Event Type
    Malfunction
    Date Received
    December 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PREVIOUSLY REPORTED CONCLUSION NO LONGER APPLIES TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: PRODUCT ID: 8711, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: NO. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT FELL IN (B)(6) 2012 AND HAD SEVERE TAILBONE PAIN FOR THE LAST THREE MONTHS. PATIENT VISITED HERE PRIMARY CARE PHYSICIAN (PCP) WHO DID X-RAYS ON (B)(6) 2012 TO SEE IF THE TAILBONE WAS BROKEN. UPON SEEING THE X-RAYS, THE PCP THOUGHT THAT THE CATHETER HAD DISLODGED; PATIENT THOUGHT "HER TAILBONE PAIN WAS CAUSED FROM THE CATHETER BEING DISLODGED". IT WAS ADDED THAT PATIENT HAD HER PUMP REMOVED A FEW YEARS AGO (REPORTED IN MFR REPORT# 3007566237-2012-03026) AND THE CATHETER WAS LEFT IN PLACE. ADDITIONAL INFORMATION RECEIVED FROM THE PCP INDICATED THAT THE "BACLOFEN PUMP WAS NOT IMPLANTED BY THEM AND THAT PATIENT'S EVALUATION WAS STILL IN PROGRESS". A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE NEUROSURGEON DID NOT FEEL THE PUMP WAS CAUSING THE PATIENT'S PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1