BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1830803 · Received September 8, 2010

    Report

    Report Number
    3004209178-2010-06869
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 16, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC REPRESENTATIVE REPORTS PT WAS IMPLANTED WITH A PADDLE LEAD IN THE CERVICAL AREA AND IMMEDIATELY AFTER SURGERY WAS EXPERIENCING LEFT UPPER EXTREMITY WEAKNESS. ABOUT A WEEK LATER, THE PT WAS TAKEN BACK TO SURGERY FOR "DECOMPRESSION" SURGERY TO RELIEVE THE PRESSURE ON THE NERVE. REPRESENTATIVE REPORTS PT SYMPTOMS ARE IMPROVING BUT HAVE NOT RESOLVED COMPLETELY AND HE IS RECOVERING AT A REHAB FACILITY.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW INDICATED THAT THE FOLLOWING INFORMATION REPORTED IN MANUFACTURER REPORT # 3004209178-2013-11720 PERTAINED TO THE EVENT REPORT UNDER THIS REPORT NUMBER. IT WAS REPORTED THE PATIENT¿S IMPLANTING PHYSICIAN ¿CRIPPLED¿ HIM; THE PATIENT¿S HEALTHCARE PROFESSIONAL (HCP) ¿BRUISED¿ HIS SPINAL CORD. IT WAS ALSO REPORTED AFTER TWO SURGERIES THE PATIENT¿S IMPLANT HAD NOT BEEN TURNED ON AND HE SPENT FOUR WEEKS IN THE HOSPITAL ABOUT FOUR YEARS AGO. ADDITIONAL REVIEW ALSO CLARIFIED THAT THE PATIENT¿S SYMPTOMS HAD RESOLVED AFTER THE IMPLANT AND DECOMPRESSION SURGERIES; HOWEVER THEY WERE STILL IN THE REHABILITATION FACILITY. ANY ADDITIONAL INFORMATION REGARDING THE INITIAL IMPLANT ISSUES AND HOSPITALIZATION WILL BE REPORTED UNDER THIS MANUFACTURER REPORT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R| S EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE153136N| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 39286-65, LOT# N212282001| LEAD: MODEL 39286-65, LOT# N121182001| EXTENSION: MODEL 37081, LOT# NJB077530V