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

Model Number	3387S-40
Medical Device Problem Code	Unintended Collision (1429)
Health Effect - Clinical Codes	Hemorrhage, Cerebral (1889); Dysphasia (2195)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a healthcare provider via a manufacturing representative about a patient with a lead implanted for parkinson's dual movement disorders.It was reported that the patient had a lead implanted for parkinson's dual movement disorders on (b)(6) 2017.A few days after the lead was implanted the patient had a fall, in which they stated they did not hit their head.The patient was admitted to the emergency room with aphasia afterwards.The patient had a ct brain scan and a small bleed, an ¿l hemorrhage¿, was observed at two points along the path of the lead at which point the patient was also admitted to the hospital.No complications or further complications were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6438657
• Report Number: 2649622-2017-02508
• Device Sequence Number: 602901
• Product Code: MHY
• UDI-Device Identifier: 00643169516540
• UDI-Public: 00643169516540
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 03/28/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2019
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA1BDYV
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2017
• Supplement Date Received by Manufacturer: 03/06/2017
• Initial Report FDA Received Date: 03/28/2017
• Supplement Report FDA Received Date: 10/02/2017
• 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: 68 YR