BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 4131568 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18042
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    August 18, 2015
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37752, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN: PRODUCT TYPE LEAD PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN: PRODUCT TYPE LEAD.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT THE PATIENT ALWAYS HAD HEADACHES, BUT THE HEADACHES HAVE GRADUALLY WORSENED IN THE LAST 3 YEARS. THIS YEAR, THE HEADACHES HAD GOTTEN EVEN WORSE. THE HEADACHES WERE KEEPING THE PATIENT UP AT NIGHT; THE PATIENT WAS TAKING TOPIRAMATE FOR THE HEADACHES. THE PATIENT ALSO HAD PAIN IN THE NECK AND HEAD; THE HEALTHCARE PROFESSIONAL THOUGHT IT WAS MIGRAINES AND THOUGHT IT COULD BE RELATED TO THE LEAD ISSUES. IT WAS NOTED THAT THE PATIENT HAD CT SCANS IN THE PAST FOR THE HEADACHES. THE PATIENT HAD 3 LEADS; ONE ON THE LEFT, ONE IN THE MIDDLE, AND ONE ON THE RIGHT. THE MIDDLE LEAD WAS INACTIVATED IN 2012 BECAUSE IT HAD MIGRATED. THE CAUSE OF MIGRATION WAS NOT DETERMINED AND THE PATIENT DENIED ANY REPORTED FALLS OR ACCIDENTS RELATED TO THE ISSUE. THE PATIENT REPORTED THAT THE SKIN AROUND THE LEAD, WHEN TOUCHED, INCITED PAIN IN THE NECK AND HEAD. THE HEALTHCARE PROFESSIONAL WAS "RULING OUT MIGRAINES FIRST BUT HAS NOT RULED OUT THE LEAD." AFTER THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED, THE PATIENT WAS TOLD THAT THE INS WAS PUT TOO LOW. THE PATIENT HAD PAIN AT THE INS SITE WHEN SHE WAS LYING DOWN OR WHEN SHE TURNED IN BED; IT WAS PAINFUL TO THE TOUCH. SHE COULD NOT WEAR A BELT AND HAD TO BE CAREFUL WITH THE WAISTLINE OF HER PANTS. IF ANYTHING TOUCHED THE INS, SHE FELT PAIN SHOOT DOWN HER LEG. NO OUTCOME WAS REPORTED FOR THIS EVENT. FURTHER FOLLOW UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THEIR HEALTHCARE PROFESSIONAL (HCP) AND THEY STATED THAT ONE OF THE PATIENT¿S ¿WIRES¿ HAD MOVED AND THE OTHER ONE HAD BROKEN. THE HCP HAD TURNED ONE OF THE LEADS OFF TWO TO THREE YEARS PRIOR TO THIS REPORT. THE INS WORKED WELL WHEN IT WAS IMPLANTED, BUT SINCE THE PATIENT HAD GOTTEN OLDER THEIR PROBLEMS HAD GOTTEN WORSE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612987 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 00042 YR