BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3030167 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04458
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 14, 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

    PRODUCT ID, 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED AN IMPLANTABLE NEUROSTIMULATOR (INS) OVERDISCHARGE WAS SUSPECTED AND THE PRIMARY REASON WAS PATIENT COMPLIANCE. IT WAS REPORTED THE PATIENT HAD BEEN TRAINED ON HOW TO RECHARGE BY TWO DIFFERENT MANUFACTURER REPRESENTATIVES AND THE PATIENT "DID NOT SEEM TO UNDERSTAND." IT WAS ALSO NOTED THERE WERE NO KNOWN PROBLEMS WITH THE INS OR THE RECHARGER AND THERE WAS "NO TROUBLE CHARGING THE INS." IT WAS STATED THE MANUFACTURER REPRESENTATIVE OFFERED TO DO A PHYSICIAN MODE RECHARGE ON THE PATIENT'S DEVICE BUT THE PATIENT WAS "NOT ABLE OR WILLING TO CHARGE." IT WAS ALSO REPORTED THE PATIENT'S WIFE STATED "THE EQUIPMENT IS FAULTY," BUT THE REPRESENTATIVE STATED ALL OF THE EQUIPMENT SEEMED TO BE WORKING AS DESIGNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) "STOPPED HOLDING A CHARGE." IT WAS FURTHER REPORTED THAT THE PATIENT "STOPPED USING THE THERAPY" BECAUSE OF THIS AND THAT THE INS "HADN'T WORKED FOR OVER A YEAR." THE PATIENT REPORTED THEY WERE TOLD THAT THE INS "WOULD NEED TO BE REPLACED." IT WAS NOTED THAT THE "BATTERY WAS DEAD." "TELEMETRY ISSUES" WERE ALSO NOTED. ADDITIONAL INFORMATION STATED THAT THE PATIENT "HAD DIFFICULTY UNDERSTANDING RECHARGING" AND THAT HE "WOULDN'T BE ABLE TO RECHARGE." IT WAS STATED THAT THE PATIENT'S PHYSICIAN "DECIDED THE BEST OPTION WAS TO GET A CONSULT FOR A REPLACEMENT WITH A PRIMARY CELL" INS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT DECIDED TO NOT HAVE THEIR DEVICE REPLACED AND DECLINED A PHYSICIAN MODE RECHARGE OF THEIR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135042 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention