BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3030190 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04459
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 14, 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

    PRODUCT ID 97791, LOT # N358517, EXPLANTED: (B)(6) 2013, PRODUCT TYPE ACCESSORY; PRODUCT ID 3776-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3776-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 97791, LOT # N358517, EXPLANTED: (B)(6) 2013, PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEADS MIGRATED FROM THE TOP OF T7 TO THE TOP OF T5. THE PHYSICIAN DID NOT KNOW WHAT HAD CAUSED THE MIGRATION. THE PATIENT EXPERIENCED PAIN AND LESS THAN 50% THERAPEUTIC RELIEF. A REVISION WAS PERFORMED DURING WHICH THE LEADS WERE PULLED BACK TO T7 AND SUTURED TO THE FASCIA WITH NO ANCHORS. THE ANCHORS WERE REMOVED AND DISCARDED. PATIENT OUTCOME AS OF THE DATE OF REPORT WAS INDICATED AS NO INJURY/NO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134158 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