MAUDE Adverse Event Report: NEURO - VILLALBA 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	Injury (2348); Post Operative Wound Infection (2446)
Date of Event	05/15/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical devices: product id 3387s-40, lot# va0g0m4, implanted: (b)(6) 2014, product type lead.
Event or Problem Description
Information was received from a health care provider (hcp) of a clinical study regarding a patient who was implanted with a neurostimulator for parkinson's dual and movement disorders.It was reported that the patient developed an infected scalp wound at the left electrode site following the implantation procedure on (b)(6) 2014.The diagnostic methods included a surgical observation on (b)(6) 2014 which resulted in the identification of the event.The etiology was noted as related to the device/therapy and related to the implant procedure; surgery/anesthesia were noted.The actions/interventions taken to resolve the issue included administering antibiotics on (b)(6) 2014.The event was considered resolved without sequelae on (b)(6) 2014.No further complications were reported/anticipated.
Additional Manufacturer Narrative
Continuation of medical devices: product id 3387s-40, lot# va0g0m4, implanted: (b)(6) 2014, product type lead.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from a manufacturer representative (rep).It was reported that the patient's baseline weight was (b)(6).It was also clarified that the previous reported diagnostics of "surgical observation" was stated to be a surgical observation during the initial implant procedure.No further complications were reported/anticipated.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): NEURO - VILLALBA; call box 6001; villalba PR 00766
• MDR Report Key: 7041295
• Report Number: 6000153-2017-00035
• Device Sequence Number: 19342113
• Product Code: MHY
• UDI-Device Identifier: 00643169313514
• UDI-Public: 00643169313514
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2018

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: 12/06/2016
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA0H2ZN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 02/06/2018
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 63