BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3722987 · Received April 2, 2014

    Report

    Report Number
    3004209178-2014-05524
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Report Date
    March 14, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37713, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3986A, LOT# N151420, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3986A, LOT# N171816, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A COMMUNICATION PROBLEM WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) LOCATED ON THE RIGHT SIDE FOR OCCIPITAL PLACEMENT. AN INS OVERDISCHARGE IS SUSPECTED. IT WAS NOTED THAT THE REP CANNOT GET COMMUNICATION WITH THE RECHARGER AND THE CLINICIAN PROGRAMMER. THE PATIENT REPORTEDLY HAD TWO RECHARGERS AND NEITHER ONE WORK ON THE RIGHT INS. THE LAST TIME ANY STIMULATION WAS REPORTEDLY FELT WAS LESS THAN ONE MONTH PRIOR TO THE DATE OF THE REPORT. IT WAS THEN NOTED THAT STIMULATION STOPPED WORKING ON (B)(6) 2014. THE LAST SUCCESSFUL RECHARGING WAS REPORTEDLY LESS THAN ONE MONTH PRIOR TO THE DATE OF THE REPORT. THE PATIENT REPORTEDLY CHARGED ON (B)(6) 2014. IT WAS NOTED THAT THE PATIENT TYPICALLY CHARGED TWICE A WEEK. IT WAS FURTHER REPORTED THAT THE PATIENT HAD NO COUPLING ISSUES AND COULD GET 8 BARS. THE PATIENT TRIED CHARGING ON THE THURSDAY PRIOR TO THE REPORT AND THE INS DID A QUICK CHARGE UP TO 100% BUT THEN QUICKLY DEPLETED AND BECAME UNRESPONSIVE, A PHYSICIAN MODE RECHARGE (PMR) WAS RECOMMENDED. IT WAS THEN REPORTED THAT THE MANUFACTURER REPRESENTATIVE USED THE CLINICIAN PROGRAMMER AND THE DEVICE REPORTEDLY CHANGED OVER TO NORMAL RECHARGING MODE AND SHE IS WORKING ON GETTING TO 25%. IT WAS FURTHER NOTED THAT THE PMR WORKED AND THE PATIENT WAS AT 75% CHARGED. IT WAS ALSO REPORTED THAT THERE WAS AN ELECTRICAL STORM AFTER WHICH THE PATIENT¿S DEVICE WAS OFF AND THEY COULD NOT COMMUNICATE WITH THEM. A PMR WAS DONE AND THE DEVICE HAD NO ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199004 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00029 YR