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

Model Number	3389S-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	11/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: 3389s-40, lot va1jz6m, implanted: (b)(6) 2017, 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 health care provider (hcp) via manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for parkinson¿s dual and movement disorders.The patient showed signs of intracranial bleeding on the right side of the brain on post-operative imaging following bilateral lead implant.Additional factors that may have led to/contributed to the event include low platelet count prior to surgery which was being monitored.Platelets were administered during surgery.The physician suspected the bleeding was a result of the platelet dysfunction and not specifically related to the deep brain stimulation (dbs) leads.A craniotomy was scheduled to evacuate the hematoma, but it was not known if the right lead or both leads would be removed in the process of the procedure.Both leads remained implanted at the time of this report and the issue was unresolved.No further complications were 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: 7071833
• Report Number: 2649622-2017-12883
• Device Sequence Number: 102614
• Product Code: MHY
• UDI-Device Identifier: 00643169516571
• UDI-Public: 00643169516571
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2017

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: 06/20/2020
• Device Model Number: 3389S-40
• Device Catalogue Number: 3389S-40
• Device Lot Number: VA1KEWR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 11/30/2017
• 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; Required Intervention
• Patient Age: 76 YR