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 Codes	Headache (1880); Pain (1994); No Code Available (3191)
Date of Event	08/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The main component of the system and other applicable components are: product id: 3389s-40, lot# va1gkt7, implanted: (b)(6) 2017, product type: lead.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider about a patient with an implantable neurostimulator (ins) for dystonia and movement disorders.It was reported that the patient had a diagnosis of pneumocephalus on (b)(6) 2017.The event was stated to be related to the patient's implant procedure.The patient was seen during normal rounds and complained of the worst pain/headache they have ever experienced.At that time diagnostic imaging (x-ray, mri, ct scan etc) was performed and the pneumocephalus was discovered, with no other intracranial abnormality.The patient spent a couple extra days in the hospital for observation.A ct scan on (b)(6) 2017 showed that the pneumocephalus had resolved, and the patient had recovered without sequelae.No further complications were reported or anticipated.[refer to manufacturer report #2649622-2017-10193 for details pertaining to the reportable related event.].
Additional Manufacturer Narrative
Weight updated.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received.It was reported that the pneumocephalus was thought to be related to the surgery and anesthesia, but the exact cause was not indicated.No further complications were reported/anticipated.

• 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: 6876774
• Report Number: 2649622-2017-10194
• Device Sequence Number: 461718
• Product Code: MRU
• UDI-Device Identifier: 00643169516571
• UDI-Public: 00643169516571
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: H020007
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2017

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: 02/22/2020
• Device Model Number: 3389S-40
• Device Catalogue Number: 3389S-40
• Device Lot Number: VA1GKT7
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 09/19/2017
• Supplement Report FDA Received Date: 11/08/2017
• 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: Hospitalization
• Patient Age: 55 YR
• Patient Weight: 102