MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number NEU_INS_STIMULATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Hemorrhage, Subdural (1894)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Elkouzi a, ramirez-zamora a, zeilman p, et al.Rescue levodopa-carbidopa intestinal gel (lcig) therapy in parkinson's disease patients with suboptimal response to deep brain stimulation.Ann clin transl neurol.2019.10.1002/acn3.50889 objective: to evaluate the effectiveness of levodopa-carbidopa intestinal gel (lcig) as an add-on rescue therapy following deep brain stimulation (dbs) for treatment of motor fluctuations.The researchers conducted a retrospective study using a large database of all medical and surgical pd cases at the university of florida.Six patients were identified with dbs who subsequently received rescue lcig therapy.The clinical histories, indications for intervention and outcomes were reviewed.Reported events: one patient had an asymptomatic subdural hematoma after initial left gpi lead lacement and elected not to have a contralateral lead placed for fear of further surgical complications.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9181222
• MDR Text Key: 170111803
• Report Number: 3007566237-2019-02113
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/11/2019
• 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
• Patient Outcome(s): Other