BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3011226 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-03919
    Event Type
    Injury
    Date Received
    March 19, 2013
    Report Date
    February 27, 2013
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONALE INFORMATION STATED THE PATIENT SAW ¿A CIRCLE WITH AN UPSIDE DOWN QUOTATION MARK¿ IN THE LEFT CORNER AND ¿A COUPLE OF DOTS, QUESTION MARK, A COUPLE OF DOTS.¿ IT WAS FURTHER DESCRIBED THAT THE POOR COMMUNICATION SCREEN WAS SEEN ON THE PROGRAMMER AND RECHARGER. IT WAS STATED THE PATIENT SAW ¿A PLUS IN THE MIDDLE OF TWO SYMBOLS¿ ON THE RECHARGER. IT WAS NOTED THE IMPLANT WAS ¿SO LOW¿ THAT IT NEEDED TO BE CHARGED. PATIENT OUTCOME WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT DID NOT FEEL STIMULATION AND THE PATIENT'S PROGRAMMER AND RECHARGER WERE NOT CONNECTING WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS ALSO REPORTED, THE PATIENT HAD NOT RECHARGED HIS DEVICE FOR TWO WEEKS AND IT WAS STATED, THE PATIENT HAD NEVER CHARGED HIS DEVICE SINCE IMPLANT. IT WAS REPORTED, AN INS OVERDISCHARGE WAS SUSPECTED, THE ANTENNA LOCATE FEATURE WAS ATTEMPTED, AND THE CALLER WAS REDIRECTED TO THE PATIENT'S HEALTHCARE PROVIDER. IT WAS ALSO REPORTED, THE PATIENT WAS SCHEDULED TO MEET WITH A HEALTHCARE PROVIDER ON (B)(6) 2013 AND WAS ALSO SCHEDULED TO HAVE HIS INS REPOSITIONED ON (B)(6) 2013 BECAUSE HE "DID NOT LIKE" HAVING THE INS IN HIS BACK. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113374 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 Required Intervention