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

Model Number 1121-60T

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Material Protrusion/Extrusion (2979)

Patient Problem Headache (1880)

Event Date 01/21/2019

Event Type  malfunction  

Event Description

It was reported to nuvectra that the patient experienced severe headache following a trial lead implant.During the surgery, the stylet protruded through the distal end of the lead where the lead tip became dislodged.A blood patch was performed which resolved the headache.

Manufacturer Narrative

An analysis was performed and the lead was found to have concentric circles extending away from the tip with a rough appearance typical of the molding process.The detection of these features is evidence that the lead did undergo the tipping and reflow process.These observations likely indicate that the root cause of the missing distal tip plug is that the reflow process was performed, but it did not sufficiently reflow the lead tip.A device history review was performed did not reveal any discrepancies that would have contributed to this event.Capa (b)(4) 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: 8343767
• MDR Text Key: 136276488
• Report Number: 3010309840-2019-00152
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1121-60T
• Device Catalogue Number: 1121-60T
• Device Lot Number: W4562958 OR W4421570
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR