BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2870239 · Received December 12, 2012

    Report

    Report Number
    3004209178-2012-11747
    Event Type
    Injury
    Date Received
    December 12, 2012
    Report Date
    November 14, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3777-45 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3777-45 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 PRODUCT ID, 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3550-39 LOT# N279649, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A POCKET REVISION DONE ON (B)(6) 2012 BECAUSE, THE DEVICE HAD CHANGED POSITIONS AND WAS UNCOMFORTABLE IN THE POCKET. IT WAS NOTED THAT SYMPTOMS INCLUDED PAIN AND THE LOCATION OF THE ISSUE WAS THE DEVICE POCKET. IT WAS ALSO NOTED THAT IMPEDANCES WERE WITHIN NORMAL RANGE AND THE PATIENT WAS ALIVE WITH NO INJURY OR ADVERSE EVENT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED CONFIRMED THAT THE CAUSE OF THE EVENT WAS THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET SITE. THE DATE OF THE REVISION PROCEDURE TO REPOSITION THE INS IN THE POCKET WAS REPORTED AS (B)(6) 2012. REPROGRAMMING WAS ALSO PERFORMED. RESULTS OF THE REVISION WERE REPORTED AS "TEMPORARY" IMPROVEMENT IN THE POCKET DISCOMFORT. THE PATIENT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELAE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention