BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3051852 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05986
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    March 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37082, PRODUCT TYPE EXTENSION; PRODUCT ID 3998, PRODUCT TYPE LEAD; PRODUCT ID 37083, PRODUCT TYPE EXTENSION; PRODUCT ID 3999, PRODUCT TYPE LEAD; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEAD HAD 'SLID OFF TO THE SIDE' AND ANOTHER LEAD WAS POTENTIALLY GOING TO BE ADDED TO ADDRESS THE SIDE OF THE PATIENT'S BODY THAT WAS NOT BEING COVERED BY THE STIMULATION DUE TO THE LEAD MIGRATION. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD STIMULATION IN THE WRONG LOCATION AND WAS POSSIBLY NOT RECEIVING THERAPY ON THE PATIENT'S RIGHT SIDE. IT WAS NOTED THAT THE PATIENT'S PHYSICIAN WANTED TO REMOVE ONE LEG OF THE PADDLE LEAD AND ADD A PERC LEAD ON THE SIDE OF THE PADDLE LEAD. IT WAS INDICATED THAT THE MANUFACTURER REPRESENTED STATED THAT 'THE PHYSICIAN DID NOT IMPLANT THE LEAD CORRECT' AND THAT THE PHYSICIAN DID NOT WANT TO REMOVE THE PADDLE LEAD. FURTHER INFORMATION RECEIVED REPORTED THAT A PERC LEAD WAS INSERTED NEXT TO THE PADDLE LEAD, WHEREIN ONE LEG OF THE PADDLE LEAD WAS REMOVED TO CONNECT TO THE PERC LEAD. AFTER THE PROCEDURE/CURRENTLY, THE PATIENT WAS RECEIVING STIMULATION ON BOTH SIDES. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152172 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