BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3925126 · Received July 10, 2014

    Report

    Report Number
    6000032-2014-00137
    Event Type
    Injury
    Date Received
    July 10, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION; PRODUCT ID 3389-40, LOT# J0337612V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD; PRODUCT ID 3389-40, LOT# J0537527V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION; PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN INTERMITTENT SHOCKING SENSATION IN THE POCKET AND AT VARIOUS TIMES. IT WAS NOTED IT HAPPENED INTERMITTENTLY SINCE THE THERAPY WAS INITIATED MANY YEARS PRIOR TO REPORT. IT WAS STATED THEY HAD TIGHTENING PERIODICALLY AT THE SKULL BUT THEY WERE UNABLE TO GIVE DETAILS ON WHEN AND WHY. IT WAS NOTED THE ISSUE WAS NOT RESOLVED AND THE CAUSE WAS NOT DETERMINED. IT WAS STATED THE PATIENT MET WITH THE MANUFACTURER REPRESENTATIVE AT THE PLANNED DEEP BRAIN STIMULATOR (DBS) BATTERY REPLACEMENT AND POSSIBLE EXTENSION REVISION ONE DAY PRIOR TO REPORT. IT WAS NOTED THEY HAD LONG-TERM INTERMITTENT SHOCKING SENSATION AT THE INS POCKET. IT WAS STATED THE REPLACEMENT WAS DETERMINED TO NOT BE NECESSARY AT THE TIME OF REPORT AS THE PATIENT ONLY USED THE THERAPY INTERMITTENTLY AT VERY LOW VOLTAGES. IT WAS NOTED THE REPLACEMENT AND EXTENSION EXPLORATION WAS CANCELLED. A PRE-OPERATIVE IMPEDANCE MEASUREMENT WAS TAKEN AND ALL WAS NORMAL. THE PATIENT STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY. IT WAS FURTHER REPORTED THE PATIENT THOUGHT A SMALLER AND THINNER LEAD SHOULD BE MADE AND THE PATIENT PROGRAMMER WAS TOO BIG AND A SMALL DEVICE SHOULD BE DESIGNED. IT WAS NOTED THE EXTENSION PRESSED BEHIND THEIR EAR AND IT WOULD IRRITATE THEIR SCALP. THEY HAD ¿ELECTRICAL SHORTS¿ IN THEIR HEAD SINCE 2000 AND AS A RESULT THEY WOULD NOT TURN THE THERAPY ON AS OFTEN. IT WAS NOTED THE SURGERY WAS CANCELLED BECAUSE THE IMPLANT BATTERY WAS BIGGER THAN THEIR CURRENT IMPLANT. ADDITIONAL INFORMATION RECEIVED REPORTED NOTHING WAS PLANNED AND THE PATIENT WAS DOING THE SAME AS WHEN THEY ARRIVED 2 DAYS PRIOR TO REPORT. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT DID NOT HAVE A 50% OR GREATER SYMPTOM REDUCTION AND THE CAUSE OF THE EVENT WAS NOT DETERMINED. IT WAS NOTED REPROGRAMMING WAS NOT NEEDED AND NO RE-OPERATION WAS PERFORMED. NO TROUBLESHOOTING OR INTERVENTIONS WERE PERFORMED AND THE PATIENT WAS NOT RECOVERED AND THEIR SYMPTOMS AND THE ISSUE WERE ONGOING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD THEIR LEFT LEAD PLACEMENT MOVED/REVISED AT THE END OF (B)(6) 2015 AND THE RIGHT SIDE WAS PLANNING TO BE MOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404433 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT SOFAMOR DANEK PUERTO RICO MFG 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention