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

Model Number 1121-60T

Device Problems Device Issue (2379); Device Operational Issue (2914); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Scar Tissue (2060)

Event Date 12/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial: device requested and to be received by manufacturer for evaluation.The device history reviews (dhrs) were reviewed for final pack lot w358291 and sterile pack lot w3298625 and there were no anomalies noted.Root cause for this event could not be determined as no device has been returned for evaluation and reviewing of the manufacturing records did not reveal any applicable discrepancies.No malfunctioned of the device could be confirmed.

Event Description

It was reported on 21 december 2016 that a patient had undergone a four day trial period for spinal cord stimulation.The physician had difficulty placing the bilateral trial leads initially.The patient presented with scar tissue/adhesions.At the end of the trial, the first trial lead was removed without difficulty.The second trial was removed with force.A portion of the distal end of the lead remained.The remainder was removed through a cut-down without complications.

Manufacturer Narrative

Date of this report 01/17/2017 updated to 02/16/2017.Date returned to manufacturer updated to 01/09/2017.Date received by manufacturer (b)(6) 2016 updated to 02/15/2017.Type of report "initial" updated to "follow-up." if follow-up, what type updated to additional information and device evaluation.Device evaluated by manufacturer "no" updated to "yes." (b)(4).Visual inspection showed the first trial lead body was partially separated from the distal end of the lead at the contacts/electrodes.The second trial lead was separated in two pieces, consisting of the distal end of the lead with contacts and one piece with contacts remaining at the proximal end of the lead.No evidence could be determined to be inherently wrong with the leads themselves that would have been present prior to the lead extractions during the trial period.

Event Description

It was reported on (b)(6) 2016 that a patient had undergone a four day trial period for spinal cord stimulation.The physician had difficulty placing the bilateral trial leads initially.The patient presented with scar tissue/adhesions.At the end of the trial, the first trial lead was removed without difficulty.The second trial was removed with force.A portion of the distal end of the lead remained.The remainder was removed through a cut-down without complications.

• 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 55499
• Manufacturer (Section G): NUVECTRA CORPORATION; 10675 naples street ne; blaine 55449
• Manufacturer Contact: amy parker ; 10675 naples street ne; blaine 55449 ; 7634047531
• MDR Report Key: 6258606
• MDR Text Key: 65026467
• Report Number: 3010309840-2016-00014
• 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: distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2017
• Device Model Number: 1121-60T
• Device Catalogue Number: 1121-60T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2015
• 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: 45 YR