BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3080141 · Received April 26, 2013

    Report

    Report Number
    3004209178-2013-06941
    Event Type
    Injury
    Date Received
    April 26, 2013
    Report Date
    April 24, 2013
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS FOUND NO SIGNIFICANT ANOMALY. IT WAS NOTED THAT THE INS BATTERY HAD REDUCED CAPACITY DUE TO OVERDISCHARGE.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; 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

    SUPPLEMENTAL SUBMITTED TO ADD CONCLUSION CODE.

    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 EXPERIENCED TELEMETRY ISSUES. AN OVER DISCHARGE OF THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS SUSPECTED. IT WAS UNKNOWN HOW LING THE INS WAS IN OVER DISCHARGE. IT WAS STATED THAT THE PATIENT RECHARGES EVERY FRIDAY AND HAD STIMULATION. IT WAS NOTED THAT 6 WEEKS PRIOR TO THE REPORT THE PATIENT'S STIMULATION "HAS NOT WORKED." THERE WAS NO COMMUNICATION BETWEEN THE INS AND THE RECHARGER. A PHYSICIAN-MODE-RECHARGE (PMR) WAS PERFORMED, AND THE PATIENT WAS SENT HOME TO CONTINUE THE PMR. IT WAS STATED THAT THE PATIENT DID NOT "COMPLETE, STOP AND CONTINUE." THE PATIENT SAW A POWER-ON-RESET (POR) MESSAGE ON THE PROGRAMMER, BUT WAS PRESSING OTHER BUTTONS ON THE RECHARGER TO BYPASS THE POR AND DID NOT SEE THE NORMAL RECHARGING SCREEN. IT WAS UNKNOWN HOW MANY "STRIKES: THE PATIENT HAD AGAINST THEIR INS. OVER TWO WEEKS LATER IT WAS REPORTED THAT THE PATIENT WAS "BEING EVALUATED" FOR A DEVICE REPLACEMENT. ABOUT 3 WEEKS LATER IT WAS REPORTED THAT HE PATIENT'S DEVICE WAS REPLACED ON (B)(6) 2013. IT WAS STATED THAT THE NEW SYSTEM WAS "FUNCTIONING WELL" AND THE PATIENT WAS "VERY PLEASED AND DOING GREAT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180801 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 Required Intervention