BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4051868 · Received September 2, 2014

    Report

    Report Number
    3004209178-2014-16241
    Event Type
    Injury
    Date Received
    September 2, 2014
    Report Date
    August 7, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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: 3550-39, LOT# N332279, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD BEEN SICK FOR 3-4 WEEKS, BUT ¿THEY DID NOT KNOW IT WAS CONNECTED.¿ IT WAS STATED THAT THE PATIENT WENT TO SEE THE HEALTHCARE PROFESSIONAL (HCP) AND WAS SENT TO THE EMERGENCY ROOM ON (B)(6). IT WAS REPORTED THAT THE PATIENT HAD BEEN IN THE HOSPITAL SINCE THEN FOR INFECTION AND ¿ALMOST SEPTIC¿ ON THE SITE OF THE IMPLANT. IT WAS REPORTED THAT THE PATIENT WAS ON AN IV, WHICH WOULD CONTINUE FOR ANOTHER 2 WEEKS. IT WAS NOTED THAT THE HCP RECOMMENDED THAT THE PATIENT SEE A SURGEON FOR THE IMPLANT, AND THE PATIENT¿S WIFE HAD CALLED TWO HCP FROM THE MANUFACTURER¿S WEBSITE, BUT THEY ¿DID NOT WANT TO TAKE THE PATIENT BECAUSE THEY DID NOT IMPLANT THE DEVICE.¿ IT WAS REPORTED THAT THE PATIENT NEEDED TO SEE A SURGEON BEFORE THE PATIENT WAS RELEASED FROM THE HOSPITAL. IT WAS NOTED THAT THE CALLER REQUESTED ASSISTANCE LOCATING A HCP. IT WAS STATED THAT THE PATIENT WAS TAKEN OFF NARCOTIC A YEAR AGO. ADDITIONAL INFORMATION RECEIVED REPORTED THAT A REQUEST FOR A MANUFACTURER¿S REPRESENTATIVE WAS MADE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT A MANUFACTURER¿S REPRESENTATIVE WOULD CALL THE PATIENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER¿S REPRESENTATIVE SPOKE WITH THE PATIENT¿S WIFE WHO STATED THAT THE PATIENT HAD AN INFECTION AND SHE WANTED TO FIND A NEW HCP. IT WAS NOTED THAT THE MANUFACTURER¿S REPRESENTATIVE PROVIDED ABOUT 10 LOCAL HCP NAMES AND THE PATIENT¿S WIFE RESPONDED ¿SHE WAS GOING BACK TO THE ORIGINAL DR.¿ IT WAS STATED THAT HE MANUFACTURER¿S REPRESENTATIVE NEVER HEARD BACK FROM THEM. IT WAS NOTED THAT THEY ONLY HAD A 1 MINUTE PHONE CONVERSATION. IT WAS STATED THAT THE MANUFACTURER¿S REPRESENTATIVE WAS NEVER TOLD OF ANY DIAGNOSIS OR ANYTHING ABOUT ONSET, SYMPTOMS, OR WHEN TREATMENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534552 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 Hospitalization| O| R