BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3920112 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-12677
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Report Date
    June 13, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 39286-65, 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 ¿HAVING ISSUES WITH THEIR MACHINE AGAIN.¿ IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2014. IT WAS FURTHER REPORTED THAT IT WAS ¿NOT DOING IT ANYMORE¿ AND THAT THE PATIENT WAS BACK ON THEIR PAIN MEDICATION AGAIN. THE PATIENT REPORTEDLY WAS RECEIVING INJECTIONS FROM THEIR HEALTH CARE PROVIDER (HCP) AS WELL. THE PATIENT REPORTEDLY WAS CHARGING THEIR IMPLANTABLE NEUROSTIMULATOR (INS) BUT IT WAS NOT HELPING. IT WAS NOTED THAT THE PATIENT WOULD WAKE UP IN PAIN AND DID SO AGAIN ON THE NIGHT PRIOR TO THE REPORT. WHEN ASKED WHEN THE EVENT OR SYMPTOMS OCCURRED THE PATIENT STATED THAT ¿IT'S GONE BACK A FEW WEEKS AGO ALREADY." IT WAS LATER REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WERE WORKING WITH THEIR HEALTH CARE PROVIDER (HCP) OR MANUFACTURER REPRESENTATIVE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT铠NEW PAIN PHYSICIAN WILL SET UP ANOTHER APPOINTMENT. 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 FURTHER STATED BY THE PATIENTS PHYSICIAN THAT THERE WAS NOT A 50% OR GREATER SYMPTOM REDUCTION. IT WAS STATED TO NOT BE DEVICE RELATED. RE-PROGRAMMING WAS NEEDED. THE PATIENT HAD REQUESTED AN ADJUSTMENT TO HELP IMPROVE PAIN CONTROL. THE PATIENT WAS UNABLE TO HAVE AN INTERVENTIONAL PROCEDURE (LUMBAR INJECTIONS) UNTIL ADJUSTMENT WAS ATTEMPTED. THE PATIENT PLANNED TO SEE A SPINAL SURGEON 2014 (B)(6) AND WAS ALSO REQUESTING REMOVAL OF THE DEVICE IF SURGERY WAS NEEDED. THE PATIENTS STATUS WAS NOT RECOVERED, SYMPTOMS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396227 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR