MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number NEU_INS_STIMULATOR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Shaking/Tremors (2515)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id neu_unknown_lead, lot# unknown, product type: lead; product id neu_unknown_prog, serial# unknown, product type: programmer, physician; product id neu_unknown_lead, lot# unknown, product type: lead.(b)(4).

Event Description

A consumer reported the patient was shaking a lot and the implant was doing absolutely nothing.Deep brain stimulation had helped the patient, but they were still shaking a lot even when stimulation had been turned up to 3.0v on both sides.If stimulation was turned off, the patient shook a lot.The reporter felt the health care provider (hcp) put the electrodes in the wrong place for the patient's parkinson's variety dystonia.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow up report will be sent.

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4996094
• MDR Text Key: 25058953
• Report Number: 3007566237-2015-02258
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Report Date: 07/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1