BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 5287187 · Received December 10, 2015

    Report

    Report Number
    3004209178-2015-24863
    Event Type
    Malfunction
    Date Received
    December 10, 2015
    Date of Event
    November 9, 2015
    Report Date
    November 16, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 74002, LOT# N223243, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ADAPTER. PRODUCT ID: 389033, LOT# J0320042V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD. PRODUCT ID: 389033, LOT# J0301151V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD. PRODUCT ID: 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM A CONSUMER VIA A MANUFACTURER REPRESENTATIVE REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS OVERDISCHARGED. A LACK OF RECHARGING LED TO THE EVENT. THEY COULD NOT USE THE RECHARGER OR PROGRAMMER TO PULL UP ANY INFORMATION. OVERDISCHARGE WAS CONCLUDED AFTER THE CONSUMER STATED THAT SHE HAD NOT RECHARGED FOR AT LEAST A COUPLE MONTHS. THE CONSUMER WANTED TO RECONVENE TO ATTEMPT TO RECAPTURE CHARGE IN THE INS. THE CONSUMER WAS TO BE CONTACTED BY A MANUFACTURER REPRESENTATIVE. NO SYMPTOMS WERE REPORTED. THE ISSUE OCCURRED DURING NORMAL USE. THE CONSUMER WAS ALIVE WITH NO INJURY. NO FURTHER OUTCOME WAS REPORTED. FOLLOW-UP WAS INITIATED TO OBTAIN THIS INFORMATION; IF ADDITIONAL INFORMANT IS RECEIVED THE EVENT WILL BE UPDATED. THE CONSUMER'S INDICATION FOR USE WAS NOTED TO BE POST LUMBAR LAMINECTOMY SYNDROME. THE MANUFACTURER REPRESENTATIVE REPORTED THAT AN ANTENNA LOCATE WAS PERFORMED BUT WAS UNSUCCESSFUL. THE PATIENT DID NOT WANT TO PURSUE A TRICKLE CHARGE AS SHE WOULD LIKE THE ENTIRE SPINAL CORD STIMULATION (SCS) SYSTEM EXCHANGED FOR A NEW SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818134 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 00063 YR