BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3070879 · Received April 22, 2013

    Report

    Report Number
    3007566237-2013-01377
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    March 24, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION/EVALUATION SUMMARY: ANALYSIS OF THE PUMP REVEALED A ¿GEAR TRAIN ANOMALY ¿ CORROSION AND/OR WEAR AND/OR LUBRICATION¿. SIGNIFICANT RESIDUE WAS FOUND ON THE UPPER SHAFT OF GEAR 2 AND THERE WAS ALSO SOME RESIDUE ON THE JEWEL WHERE THE UPPER SHAFT OF GEAR 2 INSERTS INTO THE TOP BRIDGE ASSEMBLY.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THE PATIENT RECOVERED FROM THE REPLACEMENT SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PUMP ALARM WAS HEARD ON (B)(6) 2013 AT APPROXIMATELY 4 PM. BEGINNING THE EVENING OF (B)(6) 2013, THE PATIENT EXPERIENCED ITCHING, TWITCHING, NAUSEA, VOMITING AND SPASMS IN HER LEGS. THE PATIENT VISITED THE EMERGENCY ROOM (ER) ON (B)(6) 2013 AND WAS TREATED WITH ORAL BACLOFEN. THE PUMP WAS INTERROGATED (B)(6) 2013 AND A MOTOR STALL WAS NOTED IN THE ATTENTION DIALOGUE BOX. THE PATIENT HAD NOT BEEN EXPOSED TO MAGNETIC RESONANCE IMAGING (MRI) OR ANY OTHER MAGNETIC SOURCE. THE DEVICE SYSTEM WAS DELIVERING LIORESAL. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING WITHDRAWAL SYMPTOMS SINCE (B)(6) 2013. THE CAUSE OF THE MOTOR STALL WAS UNKNOWN AND THE HCP WAS NOT ABLE TO GET THE PUMP RESTARTED. PRIOR TO THE STALL EVENT, THE PATIENT PLANNED TO HAVE THE PUMP REPLACED THIS SUMMER DUE TO NORMAL BATTERY DEPLETION, BUT INSTEAD THE PATIENT WAS CONSULTING WITH A SURGEON AND THE PLAN WAS TO REPLACE THE PUMP. IT WAS LATER REPORTED THAT ADDITIONAL WITHDRAWAL SYMPTOMS WERE REPORTED AS FLUSHING AND INCREASED SPASTICITY. THE PATIENT WAS NOTED TO BE DOING WELL ON ORAL BACLOFEN; AND WAS REPORTED TO BE MUCH IMPROVED CLINICALLY. THE PATIENT WAS REPORTED TO BE DOING "GOOD." IT WAS LATER REPORTED THE PUMP WAS EXPLANTED ON (B)(6) 2013. FOLLOWING DEVICE REMOVAL, THE PATIENT OUTCOME WAS REPORTED AS "RECOVERED WITH SEQUELA". THE PUMP WAS RETURNED TO THE MANUFACTURER AND INTERROGATED ON (B)(6) 2013. PER THE PRINT REPORT OF THE INTERROGATION, THE ESTIMATED ERI (ELECTIVE REPLACEMENT INDICATOR) WAS 13 MONTHS. THE PUMP MOTOR STALL OCCURRED (B)(6) 2013 AT TIME 1141; RECOVERY WAS STAMPED AS HAVING OCCURRED ON (B)(6) 2013 AT 1921.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172605 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00016 YR Required Intervention