BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3006470 · Received March 15, 2013

    Report

    Report Number
    3004209178-2013-03787
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3888-56, LOT# V009997, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 3888-56, LOT# V010760, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 377775, LOT# V003642, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: RECHARGER: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND NO SIGNIFICANT ANOMALY. IT WAS NOTED THE INS TESTED FUNCTIONALLY OKAY.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS 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

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT ALL OF THE IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL RANGE. IT WAS NOTED THAT THE EXPLANT WAS PERFORMED ON (B)(6) 2014. IT WAS NOTED THAT THE PATIENT WAS DOING FINE AND WAS RECEIVING EFFECTIVE THERAPY. THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S DEVICE WAS EXPLANTED. IT WAS NOTED THAT THE BATTERY DEPLETION WAS CONSIDERED NORMAL. IT WAS FURTHER NOTED THAT IMPEDANCE TESTING WAS PERFORMED. IT WAS NOTED THAT THE PATIENT EXPERIENCED BURNING AND A PAINFUL AREA AROUND THE BATTERY SITE. IT WAS NOTED THAT "IT HURT TO TOUCH THE AREA.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE HAD REACHED END OF SERVICE (EOS). IT WAS NOTED THAT THE PATIENT COMPLAINED OF BURNING AND IT WAS PAINFUL AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE. THE BATTERY DEPLETION WAS CONSIDERED NORMAL. THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELT A BURNING SENSATION IN THE AREA OF HER IMPLANTABLE NEUROSTIMULATOR (INS) POCKET. AN IMPEDANCE CHECK FOUND ALL IMPEDANCES WITHIN NORMAL RANGE. AS A RESULT OF THE EVENT, A REPLACEMENT WAS BEING SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109522 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 00058 YR Required Intervention