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

Model Number 1084-60T

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/30/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient underwent a bilateral spinal cord stimulation trial procedure utilizing the algovita spinal cord stimulation (scs) trial system with two percutanous 1084-60t, 8-electrode leads, (b)(6) 2016.The patient successfully completed the trial with excellent pain relief and the leads were extracted, (b)(6) 2016.The first lead was removed routinely.The health care professional reported resistance during extraction of the second percutaneous lead.Once the lead was free of the patient, it was determined that the distal electrode portion of the percutaneous lead remained in the patient.The patient was placed on an antibiotic regimen and bandage was placed over the implant site.Because the trial procedure was deemed successful, the patient was scheduled for a permanent scs implant.The patient underwent the procedure for a permanent scs system implant on (b)(6) 2016.During the procedure, the percutaneous lead fragment was easily removed from the epidural space without incident, and a surgical / paddle lead was successfully placed.There were no additional surgical or patient complications noted and the patient's post-operative status has been reported as fine.

Manufacturer Narrative

(b)(4).Manufacture reference number is (b)(4).Corrections: common device name: changed from "stimulator, spinal-cord, implanted (pain relief)" to "stimulator, spinal-cord, totally implanted (pain relief)".Product code: changed from "gzb" to "lgw".

Event Description

Patient underwent a bilateral spinal cord stimulation trial procedure utilizing the algovita spinal cord stimulation (scs) trial system with two percutanous1084-60t, 8-electrode leads, (b)(6) 2016.The patient successfully completed the trial with excellent pain relief and the leads were extracted, (b)(6) 2016.The first lead was removed routinely.The health care professional reported resistance during extraction of the second percutaneous lead.Once the lead was free of the patient, it was determined that the distal electrode portion of the percutaneous lead remained in the patient.The patient was placed on an antibiotic regimen and bandage was placed over the implant site.Because the trial procedure was deemed successful, the patient was scheduled for a permanent scs implant.The patient underwent the procedure for a permanent scs system implant on (b)(6) 2016.During the procedure, the percutaneous lead fragment was easily removed from the epidural space without incident, and a surgical / paddle lead was successfully placed.There were no additional surgical or patient complications noted and the patient's post-operative status has been reported as fine.

• Brand Name: ALGOVITA SPINAL CORD STIMULATION
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): NUVECTRA; 10675 naples street ne; blaine MN 55449
• Manufacturer (Section G): NUVECTRA; 10675 naples street ne; blaine MN 55449
• Manufacturer Contact: catherine vinson ; 10675 naples street ne; blaine, MN 55449 ; 7634047567
• MDR Report Key: 5831495
• MDR Text Key: 50712733
• Report Number: 3010309840-2016-00008
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 1084-60T
• Device Catalogue Number: 1084-60T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: No
• 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: 46 YR