MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION MEDTRONIC SUMMIT RC+S; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number MEDTRONIC MAF 2978, PMA P960009

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

Patient Problems Weakness (2145); Convulsion, Clonic (2222)

Event Date 05/02/2020

Event Type  Injury  

Event Description

While seated at home at approximately 2030 on (b)(6) 2020, the patient began experiencing spontaneous convulsions, primarily affecting the left body.Per patient's husband, the seizure lasted greater than 30 seconds but less than 5 minutes.The patient returned to normal level of consciousness, but reported no recall of the event.The patient was immediately transported to the emergency department for evaluation of possible seizure.The patient's head ct demonstrated no acute changes and showed all dbs leads in place.Her neurological exam appeared normal except for left sided weakness at 90% baseline.The patient was restarted on keppra 750mg twice a day and scheduled for follow-up with her neurologist.Although the patient was not receiving any brain stimulation nor was she undergoing any study-related interventions leading up to or during the event, a causal connection to the study cannot be ruled out.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC SUMMIT RC+S
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION ; minneapolis MN 55432
• MDR Report Key: 10042674
• MDR Text Key: 190604757
• Report Number: MW5094426
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MEDTRONIC MAF 2978, PMA P960009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR