BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3942135 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-13193
    Event Type
    Injury
    Date Received
    July 17, 2014
    Report Date
    June 26, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) 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) FOUND THAT THERE WAS NO ANOMALY.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED OVERSTIMULATION AND A SHOCKING OR JOLTING SENSATION. IT WAS NOTED THE PATIENT FELL DUE TO THE SHOCKING. IT WAS REPORTED REPROGRAMMING AND IMPEDANCE TESTING WERE PERFORMED. IT WAS NOTED THE OVERSTIMULATION CAUSED PAIN AT THE LEAD LOCATION THAT CAUSED THE PATIENT TO FALL. IT WAS REPORTED THE MANUFACTURER REPRESENTATIVE TURNED OFF THE PATIENT¿S SENSOR AFTER SEVERAL REPROGRAMMING ATTEMPTS. IT WAS REPORTED THE PATIENT WAS GETTING THEIR STIMULATOR REPLACED. IT WAS NOTED THE PATIENT NEEDED A NEW RECHARGER AS THE OLD ONE WOULD NOT WORK WITH THE NEWER STIMULATOR. IT WAS REPORTED THE OVERSTIMULATION AND SHOCKING OCCURRED WHILE USING THE SENSOR FUNCTION. IT WAS NOTED THE PATIENT HAD LESS THAN 50% THERAPY RELIEF. IT WAS REPORTED THE PATIENT WAS DOING WELL ASIDE FROM SURGICAL PAIN AT THE BATTERY REPLACEMENT SITE. IT WAS REPORTED THE PATIENT WAS GETTING A NEW RECHARGER.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED ON 2014-07-14 THAT EXACT DATE THAT THE PATIENT FELL WAS UNKNOWN. THE MANUFACTURER REPRESENTATIVE NOTED THAT WHEN SPEAKING WITH THE PATIENT IN PRE-OP BEFORE THE BATTERY WAS REPLACED THE PATIENT STATED THAT SHE ¿NEVER REALLY FELL BUT ALMOST WENT DOWN ON HER KNEE.¿ IT WAS NOTED THAT THE RECENT DETAILS OF THE EVENT WERE NOT WHAT THE PATIENT INITIALLY REPORTED. THE MANUFACTURER REPRESENTATIVE HAD NOT SEEN THE PATIENT SINCE THE BATTERY WAS REPLACED AND WAS NOT SURE HOW THE PATIENT¿S THERAPY WAS AS OF (B)(6) 2014. IT WAS NOTED THAT THE PATIENT HAD A FOLLOW-UP APPOINTMENT (B)(6) 2014. IT WAS ALSO NOTED THAT THE PATIENT RECEIVED THE REPLACEMENT RECHARGER ¿THE NEXT DAY.¿ IT WAS LATER REPORTED THAT THE DEVICE WAS REPLACED WITH A PRODUCT FROM THE MANUFACTURER. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS RETURNED (B)(6) 2014. IT WAS NOTED THAT THE PATIENT WAS NOT IN A CLINICAL STUDY. IT WAS LATER REPORTED THAT THE PATIENT WAS RECEIVING EFFECTIVE THERAPY ¿NOW.¿ IT WAS LATER REPORTED THAT A PATIENT PROGRAMMER WITH SERIAL NUMBER (B)(4)WAS RETURNED. THERE WAS NO KNOWN COMPLAINT REGARDING THIS PATIENT PROGRAMMER. ANALYSIS OF THE RETURNED PATIENT PROGRAMMER SERIAL NUMBER (B)(4) FOUND THAT THERE WAS NO ANOMALY. IT WAS NOTED THAT THE FACE PLATE WAS SCRATCHED. IT WAS LATER REPORTED THAT THE STIMULATION WAS PROVIDING THE PATIENT GOOD COVERAGE POST BATTERY REPLACEMENT. ANALYSIS OF THE RECHARGER SERIAL NUMBER (B)(4) FOUND THAT THERE WAS NO ANOMALY. IT WAS NOTED THAT THE COMPLAINT WAS UNVERIFIED. THERE WERE NO ISSUES FOUND DURING BENCH TESTING. IN ADDITION, THERE WERE NO ISSUES WITH CHARGING INS OR RECHARGER OR COMMUNICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420425 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention