BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3200097 · Received July 1, 2013

    Report

    Report Number
    3007566237-2013-02167
    Event Type
    Injury
    Date Received
    July 1, 2013
    Report Date
    June 7, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR, SERIAL# (B)(4), FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7426. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IPG (IMPLANTABLE PULSE GENERATOR) ON THE RIGHT SIDE HAD STIMULATION/THERAPY ISSUES AND SWITCHED OFF CONTINUOUSLY SINCE 2011. IT WAS STATED THAT SWITCHING ON THE RIGHT SIDE IPG CAUSED A SHOCKING SENSATION. IT WAS REPORTED THAT THE IPG ON THE LEFT SIDE SWITCHED OFF CONTINUOUSLY SINCE 2013. IT WAS STATED THAT THE IPG ON THE RIGHT SIDE HAD BEEN REPROGRAMMED WITH INCREASED FREQUENCY AND PULSE WIDTH AND FOR A LONG TIME THE IPG DIDN'T SWITCH OFF ANYMORE. HOWEVER, IN (B)(6) 2013, THE IPG SWITCHED OFF MANY TIMES AND THE PATIENT FELT SHOCKING SENSATION IN LEFT ARM AND LEG. IT WAS STATED THAT THE PHYSICIAN DIDN'T REVEAL ANY ANOMALIES ON THE IPG DURING A FOLLOW-UP AND IT WAS DECIDED TO REPROGRAM THE DEVICE. IT WAS STATED THAT, AFTER THIS VISIT, BOTH IPGS SWITCHED OFF MANY TIMES IN DIFFERENT PLACES WITHOUT A CORRELATION. IT WAS REPORTED THAT THE PATIENT DIDN'T FEEL FINE AT THE TIME OF THE REPORT. PATIENT STATUS AT THE TIME OF THIS REPORT WAS NOTED AS ALIVE WITH INJURY. THE DETAILS ON OF INJURY INCLUDED TREMOR, RIGIDITY, AND PARESTHESIA IN THE LEFT HAND. ACTIONS REQUIRED AS A RESULT OF THE EVENT WERE THE CHANGE OF PROGRAMMING SET. PATIENT SYMPTOMS/COMPLICATIONS WERE LESS THAN 50% THERAPY RELIEF IN THE LEFT LEG, ARM, AND HAND. TWO AND A HALF WEEKS LATER IT WAS REPORTED THAT THERE WERE NO OTHER DEVICE TROUBLESHOOTING OR REPROGRAMMING PERFORMED. IT WAS STATED THAT THE PATIENT LIVED NEAR AN ELECTRIC ENERGY SUPPLY COMPANY SO IT WAS NOT POSSIBLE EXCLUDE EMI (ELECTRO-MAGNETIC INTERFERENCE). NO TROUBLESHOOTING HAD BEEN PERFORMED WITH RESPECT TO THE LEAD/EXTENSION. IT WAS ALSO STATED THAT THE PHYSICIAN HAD NOT DOCUMENTED THE PROGRAMMING SETTING. NO SERIAL NUMBER OF EITHER IPGS COULD BE PROVIDED AT THE TIME OF THE REPORT, BUT A MEDTRONIC REPRESENTATIVE WOULD MEET WITH BOTH THE PHYSICIAN AND THE PATIENT IN 2-3 WEEKS AFTER THE REPORT AND WOULD TRY TO RETRIEVE THE INFORMATION. IT WAS STATED THAT "THE PHYSICIAN HAD DECIDED TO PROGRAM THE REPLACEMENT OF BOTH THE IPG." IT WAS STATED THAT THE PATIENT REQUESTED EMI EMISSION MEASUREMENTS IN THE ENVIRONMENT AND IT WAS UNKNOWN IF THIS HAD OCCURRED AND, IF SO, WHAT THE RESULTS WERE. THE INFORMATION WAS ALSO REPORTED ON PATIENT'S OTHER INS IN REGULATORY REPORT # 3007566237-2013-02166. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE PATIENT¿S STATUS WAS UNCHANGED. THE REPLACEMENT SURGERY FOR THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS SCHEDULED FOR ¿NEXT OCTOBER OR NOVEMBER¿. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT BOTH SOLETRA DEVICES WERE EXPLANTED AND REPLACED WITH TWO OTHER IPGS (IMPLANTABLE PULSE GENERATOR). THE PATIENT FELT FINE AND RECEIVED EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298248 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention