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 Pocket Erosion (2013); Insufficient Information (4580)

Event Date 02/29/2024

Event Type  Injury  

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

It was reported that the patient was hospitalized as the stimulator had eroded his body.Symptoms appeared.An inquiry was received if it was due to stimulation from the stimulator. it was learned from literature from other universities that there are side effects (involuntary movements, numbness, and stiffness in the muscles of the lower limbs) in patients with implanted stimulators, it was not sure whether the symptoms that appeared in the patient this time were applicable.Some symptoms have already appeared since the time it was transferred to another hospital (january 11); since the beginning of february, strong symptoms have developed that they almost fell off the bed.No device defect is known.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: Stimulator, electrical, implanted, for parkinsonian tremor
• 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: 18929984
• MDR Text Key: 338000872
• Report Number: 2182207-2024-01907
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/19/2024
• 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): Hospitalization
• Patient Sex: Male