BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2995188 · Received March 8, 2013

    Report

    Report Number
    3004209178-2013-03510
    Event Type
    Injury
    Date Received
    March 8, 2013
    Report Date
    February 15, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# V210850, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) (SERIAL # (B)(4)) FOUND THAT THE BATTERY WAS AT NORMAL END OF LIFE. NO TELEMETRY AND NO OUTPUT WERE ACHIEVED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A BATTERY REPLACEMENT SURGERY. IT WAS SUSPECTED THAT THERE WAS PREMATURE BATTERY DEPLETION. IT WAS STATED THAT THE BATTERY WENT FROM 3.72V TO COMPLETELY DEPLETED IN ONE MONTH. THE PHYSICIAN SUSPECTED A FAULTY BATTERY. THE PATIENT EXPERIENCED LESS THAT 50% THERAPY RELIEF. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO ADVERSE EVEN OR INJURY. FURTHER INFORMATION HAS BEEN REQUESTED. IF MORE INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT ATTEMPTS HAD BEEN MADE TO CONNECT TO THE BATTERY WHILE IT WAS IMPLANTED, BUT IT WAS UNDETECTABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT WAS "WELL MAINTAINED CURRENTLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99702 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention