BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 4182422 · Received October 17, 2014

    Report

    Report Number
    3004209178-2014-19942
    Event Type
    Injury
    Date Received
    October 17, 2014
    Report Date
    September 29, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION BOTH WITH AND WITHOUT THE ANTENNA ATTACHED. IT WAS NOTED THE PATIENT SAW THE REPOSITION ANTENNA SCREEN. IT WAS REPORTED THAT REPOSITIONING THE ANTENNA DID NOT RESOLVE THE ISSUE. IT WAS NOTED THE PATIENT HAD NOT USED STIMULATOR MUCH AND HAD NOT CHARGED FOR THREE MONTHS. IT WAS NOTED THE PATIENT DID NOT KNOW WHEN STIMULATION STOPPED. IT WAS NOTED THE PATIENT¿S PROGRAMMER WOULD NOT CONNECT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY, BUT THEY WERE WORKING WITH THEIR HEALTHCARE PROFESSIONAL. THE PATIENT HAD AN APPOINTMENT WITH THEIR HEALTH CARE PROFESSIONAL ON (B)(6) 2014. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A ¿DEVICE MALFUNCTION¿ AND THE PATIENT HAD DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). IT WAS NOTED THAT THE SPINAL CORD STIMULATION (SCS) WAS NOT WORKING FOR PAIN IN THE RIGHT LOWER EXTREMITIES. IT WAS NOTED THAT THERE ABNORMAL IMPEDANCES ON (B)(6) 2014. A THORACIC X-RAY WAS DONE ON (B)(6) 2014 AND THE LEAD HAD MOVED. IT WAS NOTED THAT THE PATIENT WAS SCHEDULED FOR A SCS REVIEW. NO INTERVENTIONS OR OUTCOME WERE 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.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS SCHEDULED FOR A SPINAL CORD STIMULATION REVISION. THE FOLLOWING INFORMATION PREVIOUSLY REPORTED NO LONGER PERTAINS TO THIS EVENT: IT WAS NOTED THAT THE PATIENT WAS SCHEDULED FOR A SCS REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661568 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention