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

Model Number 3387-28

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Dysphasia (2195)

Event Date 04/09/2015

Event Type  Injury  

Event Description

It was reported that there was a subcortical hematoma on the frontal left lead trajectory during the procedure.Symptoms included dysarthria and language trouble at testing phase.It was unknown what had led to this event.Diagnostics included imaging with abnormal results of subcortical hematoma on frontal left lead trajectory.Interventions included interrupting the procedure.The left lead remained implanted and the right lead was not implanted.The issue was resolved.This was procedure related.The outcome was resolved without sequelae.

Manufacturer Narrative

Concomitant products: product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension.Product id: 37603, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator.(b)(4).

• 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: 4957760
• MDR Text Key: 6255452
• Report Number: 6000153-2015-00156
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2018
• Device Model Number: 3387-28
• Device Catalogue Number: 3387-28
• Device Lot Number: 0209237330
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/10/2015
• Initial Date FDA Received: 07/31/2015
• Date Device Manufactured: 10/20/2014
• 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: 00063 YR