MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION 3058 NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Incontinence (1928)

Event Date 03/24/2020

Event Type  Injury  

Event Description

Medtronic 3058 neurostimulator serial no: (b)(4), implanted on (b)(6) 2020 by physician dr (b)(6) has never worked properly.There hasn't been any improvement in the bladder control problems of the patient.The instructions from the physician to the patient were to call a "medtronic technician" for support after the device was implanted, but he is not answering the patient calls anymore.The bladder discharges are disabling the patient.Needs help immediately and no one is responding, neither the doctor or the technician.Fda safety report id# (b)(4).

• Brand Name: 3058 NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 11045773
• MDR Text Key: 224834803
• Report Number: MW5098455
• Device Sequence Number: 1
• Product Code: EZW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3058
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 76 YR
• Patient Weight: 63