BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3971757 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-13788
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    July 10, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION; PRODUCT ID 3487A-33, LOT# J0427678V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD; PRODUCT ID 74001, LOT# N348224, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: ADAPTER; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STIMULATION WOULD TURN ON AND ¿THEY¿ OFF BY ITSELF. THE PATIENT ALSO REPORTED THAT THERE WAS A PROBLEM WITH THE PATIENT PROGRAMMER. IT WAS NOTED THAT THE PATIENT WAS NOT ABLE TO MAKE ADJUSTMENT WITH OR WITHOUT THE ANTENNA ATTACHED. THE PATIENT ALSO STATED THAT THE CONNECTION WAS INTERMITTENT AND SHE MUST TRY IT FIVE OR SIX TIMES BEFORE THE PROGRAMMER WOULD ¿SPEAK¿ WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). THE MANUFACTURER REPRESENTATIVE NOTED TO TRY WITH THE ANTENNA AS WELL. THE PATIENT NOTED THAT DID NOT HELP THE ISSUE. THE PATIENT STATED THAT THE PROGRAMMER HAD BEEN DROPPED ¿A COUPLE TIMES¿ ONTO CARPET FLOORING AT WORK BECAUSE THE PATIENT ONLY NEEDED STIMULATION WHEN SITTING AND NOT WHEN STANDING. IT WAS FURTHER REPORTED THAT THE PATIENT WAS NOT ABLE TO CONNECT WITH OR WITHOUT THE EXTERNAL ANTENNA. THE ANOMALY APPEARED TO HAVE OCCURRED THROUGH PRODUCT USE. THE PATIENT CALLED BACK (B)(6) 2014 AND REPORTED THAT SHE RECEIVED A NEW PROGRAMMER BUT SOMETIMES OBSERVED THE 006 CODE ON THE PATIENT PROGRAMMER. THE PATIENT NOTED THAT SHE DID NOT HAVE TIME TO WAIT FOR A PATIENT PROGRAMMER WHEN SHE HAD TO WORK. IT WAS FURTHER REPORTED THAT THE PATIENT WOULD TRY THE REPLACEMENT PATIENT PROGRAMMER LONGER BECAUSE THE 006 CODE ONLY CAME ON SOMETIMES. THE PATIENT WOULD CALL BACK IF SHE HAD ISSUES. THERE WAS NO PRODUCT SENT. ANALYSIS OF THE PATIENT PROGRAMMER WITH SERIAL NUMBER (B)(4) FOUND THAT THERE WAS NO ANOMALY. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY. A MANUFACTURING REPRESENTATIVE HELPED THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448160 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 00053 YR