MAUDE Adverse Event Report: NEURO - VILLALBA ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 3389-40

Device Problems High impedance (1291); Unexpected Therapeutic Results (1631); Impedance Problem (2950)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3389-40, lot# v066176, implanted:(b)(6) 2008, product type: lead.Product id: 37612, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator.Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2008, product type: extension.Product id: 64001, lot# n481237, implanted: (b)(6) 2015, product type: adapter.Product id: 64001, lot# n481237, implanted: (b)(6) 2015, product type: adapter.Product id: 3389-40, lot# v066176, implanted: (b)(6) 2008, product type lead.(b)(4).

Event Description

A manufacturing representative reported that high electrode impedances were measured and the impedances were fluctuating.The manufacturing representative was not sure if the patient was programmed using the electrodes with high impedance.The implantable neurostimulator (ins) was on at the time of this report.The patient's tremor was controlled, but they felt their current ins was not as good as their previous ins.The manufacturing representative planned to meet with the patient the following week.Additional information received from a manufacturing representative reported that the patient had a revision scheduled for (b)(6) 2016.The manufacturing representative was unsure if the surgery was for a revision or more exploratory to try and find the location of the impedance issue.The cause of the impedance issue was unknown.The manufacturing representative clarified their comments about the device n ot working as well as the patient's last device.The manufacturing representative was referring to the impedance issue when they made that comment.A manufacturing representative later reported the lead was replaced.The patient's indication for use is parkinson's dual and movement disorders.Refer to manufacturer report #3004209178-2015-23638\.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): NEURO - VILLALBA; call box 6001; villalba PR 00766
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5379259
• MDR Text Key: 36413230
• Report Number: 6000153-2016-00153
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2010
• Device Model Number: 3389-40
• Device Catalogue Number: 3389-40
• Device Lot Number: V007803
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2016
• Date Device Manufactured: 05/25/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 00065 YR