BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3844183 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-10002
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Report Date
    May 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A COMMUNICATION PROBLEM WAS ENCOUNTERED. IT WAS STATED THAT THE PATIENT NOTICED THAT PROBLEM ABOUT ONE WEEK AGO. IT WAS STATED THAT THE PATIENT USUALLY LET IT DEPLETE COMPLETELY AND THEN RECHARGED. IT WAS STATED THAT THE PATIENT LAST FELT STIMULATION ABOUT A COUPLE DAYS BEFORE IT DEPLETED. IT WAS STATED THAT THE PATIENT DID NOT USE THE BELT WHEN SHE RECHARGED. IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) FELT FLUSH AND ¿THERE WAS A LITTLE BIT MORE MOVEMENT IN THE POCKET THAN BEFORE¿. IT WAS REPORTED THAT THE PATIENT HAD A SHOCKING OR JOLTING SENSATION. IT WAS STATED THAT THE PATIENT NOTICED THIS CHANGE WHEN HER INS DEPLETED ABOUT A WEEK AGO AND IT ONLY OCCURRED WHEN SHE WAS LYING DOWN. IT WAS MENTIONED THAT IN (B)(6) 2014 SHE DID HAVE A FALL, HOWEVER THE PATIENT STATED SHE WAS ABLE TO TURN IT BACK ON AND HASN'T NOTICED ANY CHANGES UNTIL NOW WITH THE SHOCKING. IT WAS STATED THAT THE SHOCKING OCCURRED AT THE INS LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322023 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 00036 YR