MAUDE Adverse Event Report: NEURO - VILLALBA ACTIVA

Model Number 37602

Device Problems High impedance (1291); Unintended Collision (1429)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: 3387s-40, serial/lot #: (b)(4), ubd: 03-sep-2011, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient's system was checked prior to a scheduled mri and red x-high impedances were found for the left lead for contact 3.It was determined that the patient was not eligible for mri and the managing physician was informed that the mri was not completed.The patient had a fall a few weeks ago.No interventions were taken to resolve the issue.The issue was not resolved.No patient symptoms were reported.

• Brand Name: ACTIVA
• Manufacturer (Section D): NEURO - VILLALBA; call box 6001; villalba PR 00766
• Manufacturer (Section G): NEURO - VILLALBA; call box 6001; villalba PR 00766
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12487646
• MDR Text Key: 271884676
• Report Number: 6000153-2021-00051
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000100346
• UDI-Public: 00763000100346
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2021
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2021
• Initial Date FDA Received: 09/17/2021
• Date Device Manufactured: 02/18/2020
• 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 Age: 69 YR