MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN 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 Edema (1820); Emotional Changes (1831); Headache (1880); Dysphasia (2195); Depression (2361); Skin Inflammation (2443); Test Result (2695)

Event Date 11/18/2015

Event Type  Injury  

Manufacturer Narrative

The main component of the system.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown, trezza, a., landi, a., pilleri, m., antonini, a., giussani, c., sganzerla, ep.Peri-electrode edema after bilateral subthalamic deep brain stimulation for parkinson's disease.J neurosurg sci.2018;62(1):103-105.Doi: 10.23736/s0390-5616.16.03421-4.If information is provided in the future, a supplemental report will be issued.

Event Description

Summary/reported events: a (b)(6)-year-old man who received bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) for parkinson's disease (pd) experienced transient symptomatic peri-electrode edema.The surgery and initial postoperative course was reportedly regular without any complications and they were discharged after 4 days.Five days after discharge (postoperative day 9) the patient presented at the emergency department of the authors¿ institution complaining behavioral changes characterized by apathy, depression, speech difficulties (anomies and lowering of the verbal fluency) and headache.Head contrast-enhanced ct scan showed hypodense subcortical areas surrounding both electrodes (figure 1) with no signs of cerebritis.Cerebrospinal fluid sampling and blood tests resulted negative.Electroencephalography did not show any epileptic or pathological activity.The authors noted that they performed a patch test using fragments of a dbs lead to assess the patient¿s reactivity to the main components, iridium, platinum and polyurethane; they found the patient showed a slight positivity in the form of skin blisters, but they felt this was not surely related to a possible allergic reaction.The patient was treated by steroid (dexamethasone 8 mg twice a day, tapered in 15 days) and fully recovered cognitive functions, verbal fluency and mood state.Postoperative unified parkinson's disease rating scale (updrs) scores reportedly showed improvement on stimulation, and ct scans showed progressive reduction until complete resolution of the brain edema.The patient had progressively improved with a full recovery in a few months, with no recurrence for at least up to 1-year post implant.It was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.

• Brand Name: UNKNOWN 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: 7334908
• MDR Text Key: 102248217
• Report Number: 3007566237-2018-00756
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2018
• 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): Required Intervention
• Patient Age: 49 YR