MAUDE Adverse Event Report: MPRI ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	3387S-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seizures (2063)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other applicable components are: product id: 3387s-40, lot# va1uxku, implanted: (b)(6) 2018, product type: lead.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider (hcp) regarding a patient who was implanted with a neurostimulator (ins) for an unknown dbs therapy, it was reported that the patient had developed seizures days after the implant.There are no known factors that could've caused the event, and no known actions/interventions.The patient was hospitalized, and the issue was said to have resolved.More information would be gathered on (b)(6) 2018.No additional surgical intervention was planned.There were no further complications reported.
Additional Manufacturer Narrative
Other applicable components are: product id: 3387s-40, lot# va1uxku, implanted: (b)(6) 2018, product type: lead.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received: it was reported by the rep via the doctor that the patient¿s seizures were not from a pre-existing condition.The exact relationship between the devices and the seizures is unknown, but the patient started having seizures, as reported by their family, sometime in the week after the leads were placed in the brain.The stimulation was not on as the patient didn't have the ipg placed due to their seizures.It was again stated that the seizures developed after the brain electrodes were placed, although the seizures were not during the surgery.A ct of the brain had shown that the area of the abnormality not believed to be infection.The patient was hospitalized and placed on anti seizure medications.They were still taking anti seizure medications and were no longer inpatient.There were no further complications reported.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 8124992
• Report Number: 2649622-2018-19739
• Device Sequence Number: 2364240
• Product Code: MHY
• UDI-Device Identifier: 00643169313491
• UDI-Public: 00643169313491
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/02/2021
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA1UXKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other