BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3019268 · Received March 25, 2013

    Report

    Report Number
    3004209178-2013-04171
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Report Date
    June 14, 2018
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377775, LOT# V010773, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID NEU_UNKNOWN_LEAD, IMPLANTED: UNK, EXPLANTED: (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377775, LOT# V010773, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD: PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVIEW DETERMINED CONCLUSION CODE (B)(4) NO LONGER APPLIES TO THIS EVENT IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S PROGRAMMER WOULD NOT TURN ON THEIR IMPLANT. IT WAS NOTED THE PATIENT WANTED STIMULATION ON BOTH THEIR RIGHT AND LEFT SIDE, AND WERE ONLY GETTING STIMULATION ON THEIR LEFT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED STIMULATION IN THE WRONG AREA. IT WAS NOTED THAT THE PATIENT DID NOT GET STIMULATION ON THEIR RIGHT SIDE. IT WAS STATED THAT THE PATIENT REPORTED HIGH IMPEDANCES, >10,000 OHMS. IT WAS ADDED THAT IMPEDANCES FOR ELECTRODES 0-7 WERE OKAY, BUT ELECTRODES 8-11 SHOWED 2 ELECTRODES >10,000 OHMS, AND ELECTRODES 12-15 ARE ALL >10,000 OHMS. IT WAS ADDED THAT PROGRAMMING AROUND THE "TWO ELECTRODES ON THE QUAD LEAD THAT WERE OUT OF IMPEDANCE" AND AN X-RAY OF THE LEAD PLACEMENT WAS DONE. IT WAS STATED THAT THE PATIENT HAD A PREVIOUS REVISION. IT WAS NOTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. IT WAS ADDED THAT THE SHOCKING SENSATION OCCURRED AROUND THE WEEK OF (B)(6) 2013. IT WAS STATED THAT THE PATIENT EXPERIENCED A "FADING" SENSATION. IT WAS NOTED THAT THE PATIENT WOULD HAVE A SURGICAL PROCEDURE ON (B)(6) 2013 TO FIX THE LEAD ISSUE AS WELL AS IMPLANTING A NEW BATTERY. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED BOTH LEADS AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WERE REPLACED. THERE WERE TWO BAD ELECTRODES ON A "QUAD" ELECTRODE LEAD, AND THE PATIENT'S OTHER LEAD, AN "OCTAD" LEAD, WAS DAMAGED DURING THE PROCEDURE BY THE SURGEON SO IT WAS REPLACED AS WELL. THE PATIENT WAS RECOVERING FROM SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122553 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