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

Model Number 3708660

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

Patient Problems Stroke/CVA (1770); Intracranial Hemorrhage (1891); Weakness (2145)

Event Date 12/30/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 37612, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator.Other relevant device(s) are: product id: 37612, serial/lot #: (b)(4), ubd: 14-apr-2014, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient needed an mri of the head stating the hcp was unaware of the patient having a brain bleed or minor stroke, and ¿things had gotten worse¿ and was ¿weak on one side.¿ the patient stated the event was unrelated to the mri, but hcp was unsure of the root cause of the incident.The patient stated the dbs was implanted to trigeminal neuralgia.The patient mentioned they worked with the doctor but moved and was unsure of who took their place.It was recommended for the patient to call the previous managing doctor for assistance in filling out the mri form.The patient wanted to find an hcp closer but couldn't find a managing physician for their indication.

• 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): NEURO - VILLALBA; call box 6001; villalba PR 00766
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9717575
• MDR Text Key: 188996778
• Report Number: 6000153-2020-00006
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994749116
• UDI-Public: 00613994749116
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2017
• Device Model Number: 3708660
• Device Catalogue Number: 3708660
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2020
• Date Device Manufactured: 06/19/2013
• 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): Other
• Patient Age: 62 YR