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 Codes	Edema (1820); Complaint, Ill-Defined (2331)
Date of Event	10/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other applicable components are: product id neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator.
Event or Problem Description
Information was received from a manufacturers' representative regarding a patient who was implanted with a neurostimulator for movement disorders.It was reported that following the first surgery when the leads were implanted a post-op ct and mri revealed edema around the lead.Follow-up from representative stated that the patient was still inpatient but they did not have any information regarding specific treatments the patient was receiving.
Event or Problem Description
Follow up information received from the healthcare provider (hcp) reported that no actions/interventions were taken to resolve the edema.It was stated that the patient's symptoms resolved and they don't know the significance of the mri changes.
Additional Manufacturer Narrative
Upon review of the additional information received, it was determined that patient code (b)(4) should be added.
Event or Problem Description
Additional information was received from a health care provider (hcp).It was reported that a ct scan showed an edema along the path of the lead without evidence of infection.The hcp also commented that this patient was generally in poor health and never had their leads connected to the implantable neurostimulator (ins).The edema was treated with steroids and eventually resolved.
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: 6089460
• Report Number: 2649622-2016-13846
• Device Sequence Number: 16383200
• Product Code: MHY
• UDI-Device Identifier: 00643169516540
• UDI-Public: 00643169516540
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/05/2017

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: 06/20/2019
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA19CKJ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/21/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; 12/12/2016
• Initial Report FDA Received Date: 11/09/2016
• Supplement Report FDA Received Date: 12/15/2016; 01/05/2017; 09/27/2017
• 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; Required Intervention
• Patient Age: 67 YR