BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4061457 · Received September 4, 2014

    Report

    Report Number
    3004209178-2014-16409
    Event Type
    Injury
    Date Received
    September 4, 2014
    Report Date
    August 11, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4). ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND THAT THE INS BATTERY HAD A REDUCED CAPACITY DUE TO OVERDISCHARGE. THE INS WAS RECEIVED IN AN OVERDISCHARGED CONDITION WITH NO TELEMETRY AND NO OUTPUT. TELEMETRY WAS RESTORED AFTER PERFORMING A PHYSICIAN MODE RECHARGE AND RECHARGING THE INS BATTERY. THE INS THEN PASSED FUNCTIONAL TESTING. ACCORDING TO THE TRACE REPORT TAKEN FROM THE INS, THE OVERDISCHARGE COUNT WAS 2. IT COULD NOT BE DETERMINED FROM THE TRACE REPORT WHEN THE OVERDISCHARGES HAD OCCURRED BECAUSE THE CLOCK HAD NEVER BEEN RESET TO THE CURRENT DATE AND TIME AFTER THE FIRST OVERDISCHARGE CAUSED THE TIME TO DEFAULT TO (B)(6) 2000. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS OVERDISCHARGED. IT WAS NOTED THAT IT WAS UNKNOWN HOW LONG THE PATIENT HAD BEEN IN OVERDISCHARGE. IT WAS FURTHER NOTED THAT TELEMETRY ISSUES WERE REPORTED. THE REPORTER STATED THE PATIENT HAD SOMEONE CLEAN THEIR HOUSE AND THEY TOOK THE PATIENT¿S RECHARGER SO THEY WERE NOT ABLE TO RECHARGE. IT WAS NOTED THE PATIENT HAD BEEN GIVEN A NEW RECHARGER. LATER, THE PATIENT DID TWO TRICKLE CHARGES AND WAS ABLE TO FULLY CHARGE THEIR INS. IT WAS NOTED THE PATIENT HAD GOOD STIMULATION COVERAGE AND WAS HAPPY. IT WAS FURTHER NOTED THE PATIENT HAD THEIR RECHARGE BAG STOLEN WITH THEIR PATIENT PROGRAMMER. THE REPORTER STATED THEY OVERNIGHTED THE PATIENT ANOTHER ONE AND EVERYTHING WAS FINE. LATER, ON INFORMATION RECEIVED (B)(6) 2014, IT WAS REPORTED THAT THE INS WAS EXPLANTED OR OUT OF SERVICE ON (B)(6) 2014. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542868 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention