BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2000302 · Received February 17, 2011

    Report

    Report Number
    3004209178-2011-01192
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 28, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL DEVICE ANALYSIS OF THE EXTENSION (LOT # NKC015281N) AND THE FIRST ANCHOR REVEALED NO ANOMALY FOUND. FINAL DEVICE ANALYSIS OF THE LEAD (LOT # UNK) REVEALED NO SIGNIFICANT ANOMALIES. THE LEAD WAS OK, BUT THERE WERE MULTIPLE COSMETIC CUTS IN THE MOLDED RUBBER STRAIN RELIEF ON THE DISTAL END OF THE LEAD, AND MULTIPLE COSMETIC MELTED SPOTS IN THE OUTER INSULATION. BOTH THE CUTS AND MELTED SPOTS WERE FELT TO BE SUSPECTED EXPLANT DAMAGE. THE LEAD WAS TESTED WITH THE EXTENSION AND CONTINUITY WAS ACCEPTABLE ON ALL CIRCUITS. FINAL DEVICE ANALYSIS OF THE SECOND ANCHOR REVEALED NO SIGNIFICANT ANOMALIES. THE ANCHOR HAD BEEN CUT TO A CUSTOM LENGTH BY THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S LEAD WAS REPLACED DUE TO UNCOMFORTABLE STIMULATION IN THE RECTUM. IT WAS REPORTED BY THE PT'S HEALTH CARE PROVIDER (HCP) THAT THE PT DID WELL POST-IMPLANT, BUT OVER TIME REQUIRED HIGHER VOLTAGE. THE INCREASED VOLTAGE "CAUSED UNCOMFORTABLE RECTAL STIMULATION." THE PT'S LEAD WAS REPLACED. AFTER REPLACEMENT SURGERY, THE PT AGAIN RECEIVED GOOD STIMULATION WITHOUT RECTAL STIMULATION. THE PT OUTCOME WAS REPORTED AS "NON-SERIOUS INJURY/ILLNESS." THE DATE OF THE SURGERY WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention EXPLANTED:| EXPLANTED:| IMPLANTED:| STIM ACCESSORY: MODEL ANCHOR, LOT # UNK| IMPLANTED:| STIM ACCESSORY: MODEL 3550-39, LOT # UNK| EXPLANTED:| LEAD: MODEL 3587A, LOT # UNK| EXPLANTED:| EXTENSION: MODEL 37083, LOT # NKC015281N| IMPLANTED:| IMPLANTED: