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

Model Number NEU_ENS_STIMULATOR

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

Patient Problems Dysphasia (2195); Convulsion/Seizure (4406); Swelling/ Edema (4577)

Event Date 07/11/2022

Event Type  Injury  

Event Description

It was reported that after implanting the lead the patient developed aphasia 7 days after implant, and 10 days after implant the patient had an epileptic fit.The hospital had identified perifocal lead edema.The edema started in the pre-frontal subcortical area and usually showed some progression along the lead trajectory at first image control.The neurosurgeon only used latex free gloves and avoids systematically any contamination of implant material or gloves with bone dust or disinfectants.The patient was aphasic.The patient was given medications but the issue was not resolved.

Manufacturer Narrative

Concomitant medical products: product id: b3300533, serial#: (b)(4), implanted: (b)(6) 2022, product type: lead.Other relevant device(s) are: product id: b3300533, serial/lot #: (b)(4), ubd: 17-mar-2024, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: EXTERNAL 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: 15085126
• MDR Text Key: 296396420
• Report Number: 2182207-2022-01419
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2022

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_ENS_STIMULATOR
• Device Catalogue Number: NEU_ENS_STIMULATOR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 07/22/2022
• 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: 70 YR
• Patient Sex: Male