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

Model Number NEU_INS_STIMULATOR

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

Patient Problems Emotional Changes (1831); Depression (2361); Swelling/ Edema (4577)

Event Date 04/28/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id b3300533 lot# serial# (b)(4) implanted: (b)(6) 2021 explanted: product type lead.Product id b3300533m lot# serial# (b)(4); implanted: (b)(6) 2021 explanted: product type: lead.Information references the main component of the system.Other relevant device(s) are: product id: b3300533, serial/lot #: (b)(4); ubd: 26-feb-2023, udi#: (b)(4).Product id: b3300533m, serial/lot #: (b)(4); ubd: 26-feb-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported after implant of sensight leads the patient developed 5 days after implant an apathy and depression and the hospital identified an perifocal lead oedema.The oedema started in the pre-frontal subcortical area and usually showed some progression along the lead trajectory at first image control.The neurosurgeon only uses latex free gloves, and avoids systematically any contamination of implant material or gloves with bone dust or desinfectants.After a while the neurosurgeon evalutated a full recovery from the symptoms.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15099660
• MDR Text Key: 296561730
• Report Number: 2182207-2022-01439
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• 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
• Date Manufacturer Received: 07/15/2022
• 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
• Patient Age: 53 YR
• Patient Sex: Male