MAUDE Adverse Event Report: NEURO - VILLALBA 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	Abscess (1690); Scar Tissue (2060); Skin Inflammation (2443)
Date of Event	07/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information references the main component of the system and other applicable components are: product id neu_unknown, implanted: (b)(6) 2013 explanted: (b)(6) 2018, product type connector boot.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider (hcp) of a clinical study regarding a patient with an implantable neurostimulator (ins).It was reported that the patient developed a small pimple-like area over the connector boot that gradually increased in size and drainage.The patient had reported it as a blister.The connector boots were replaced and the lesion was excised.Surgical observation indicated hyperreactive scar tissue as well.The event resolved without sequelae on (b)(6) 2018.The etiology was stated to be possibly related to the device/therapy and not related to the implant procedure.No further complications were reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from the hcp stating no cause of the patient's lesion was indicated.No device issue was indicated.No contributing factors or circumstances related to the onset of the lesion were noted.

• 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: 8057479
• Report Number: 6000153-2018-00018
• Device Sequence Number: 13821347
• Product Code: MHY
• UDI-Device Identifier: 00613994981363
• UDI-Public: 00613994981363
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2019

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: 07/29/2016
• Device Model Number: 3389S-40
• Device Catalogue Number: 3389S-40
• Device Lot Number: VA0CLTX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 11/09/2018
• Supplement Report FDA Received Date: 01/24/2019
• 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: 55 YR