MAUDE Adverse Event Report: NUVECTRA CORPORATION ALGOVITA SPINAL CORD STIMULATION; STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF)

Model Number 1124-60T

Device Problems Detachment of Device or Device Component (2907); Material Protrusion/Extrusion (2979)

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

Event Date 02/14/2019

Event Type  malfunction  

Event Description

It was reported to nuvectra that during implant of a trial lead, the stylet protruded through the distal end of the lead.A new trial lead was implanted and no impact to the patient.

Manufacturer Narrative

The reported complaint was unable to be confirmed.The device was not returned for analysis.A device history review was performed did not reveal any discrepancies that would have contributed to this event.Capa-00048 has been initiated to address the issue.

• Brand Name: ALGOVITA SPINAL CORD STIMULATION
• Type of Device: STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF)
• Manufacturer (Section D): NUVECTRA CORPORATION; 10675 naples street ne; blaine MN 55449
• MDR Report Key: 8424145
• MDR Text Key: 139090868
• Report Number: 3010309840-2019-00169
• Device Sequence Number: 0
• Product Code: LGW
• PMA/PMN Number: P130028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/25/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2020
• Device Model Number: 1124-60T
• Device Catalogue Number: 1124-60T
• Device Lot Number: W4519250
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR