BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2822591 · Received November 7, 2012

    Report

    Report Number
    3004209178-2012-09993
    Event Type
    Injury
    Date Received
    November 7, 2012
    Report Date
    October 9, 2012
    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 3777-45, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE RECHARGER, PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) (SERIAL # (B)(4)) FOUND NO ANOMALY. THE DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. TESTING OF THE RECHARGE FUNCTION OF THIS INS FOUND IT TO BE FUNCTIONING NORMALLY. THE BATTERY CHARGED WITH 100% COUPLING. THE INS WAS RECHARGED TO FULL. THE RETURNED INS BATTERY LASTED APPROXIMATELY 12.7% LESS TIME THAN A NEW BATTERY, WHICH WAS IN THE NORMAL RANGE FOR A USED BATTERY OF THIS AGE.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RECHARGE INTERVAL OCCURRED MORE FREQUENTLY. A REVISION WAS REQUIRED AND THE BATTERY WAS REPLACED. IT WAS FURTHER REPORTED THAT THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS EVENT AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention