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

Model Number 2412

Device Problem High impedance (1291)

Patient Problems Therapeutic Effects, Unexpected (2099); Injury (2348)

Event Date 08/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Due to issues with the portal set up process, this mdr has not been submitted.Nuvectra is actively working with the esg helpdesk at the fda ((b)(4)).

Event Description

On (b)(6) 2016 it was reported that the patient's stimulation was off and she was unable to start the stimulation.The ipg would not connect to the cp.It was possible to charge with the ppc and the ipg showed 3 bars.After charging with the ppc the connection between the cp and ipg was possible.The program was started and the patient felt the stimulation in the right spot.After a short period of time, the stimulation stopped when the patient moved.The impedances on both leads changed from normal to high.When the patient was not moving, all impedances were green.The patient was ok but without stimulation.On (b)(6) 2016, ipg, serial number (b)(4) was explanted and a new ipg was implanted.The leads were found to be in tact and are connected to the newly implanted ipg.There were no complications and patient is receiving therapy with the new ipg.

Manufacturer Narrative

(b)(4).Note to file: due to issues with the portal setup process and access, the initial report could not be submitted within 30 day (see esg tickets (b)(4)).Investigation: the device was evaluated by electrical engineer subject matter expert (sb).The device was found to have multiple issues with output pulse performance during device level functional stimulation testing, such as erratic impedance measurements and excessive channel crosstalk.Further testing required access to the inner components of the stimulator.The device was disassembled; all inner components were removed from the case and visually inspected.Visual inspection did not identify any damages or abnormalities.The printed circuit assembly ((b)(4)) was subjected to board level electrical testing.During manual testing of the pcb, the same impedance and crosstalk issues were observed to occur as were observed on the sealed ipg.However, after running the pcb through an automated test process, which includes reloading the device firmware and constants, the pcb functioned normally and no longer exhibited the issues.The board was then reloaded with the patient program that was received with the complaint device the dut operated nominally, with expected levels of channel crosstalk, no detectable "stim startup transients" and impedance measurement performance that meets specification.Numerous follow up tests were conducted over a two-week period while the dut was in continuous operation outputting various therapy programs; no deviation from expected nominal performance has been noted in those observations.The contract manufacturer of the device was notified of the issue.A process review identified that all inspections and functional tests met specification and acceptance criteria.The dhr review did not identify any anomalies that would be associated with this issue.Review of the manufacturing process did not identify a root cause for the issue.Root cause: no root cause identified.Conclusions: as received, the returned ipg showed issues with output pulse performance and impedance measurements during bench testing.During further investigation the pca was destructively removed from the returned device, and was subjected to board level electrical testing to determine a root cause for these anomalies.The extracted pcb initially demonstrated the same issue as with the sealed ipg, however, these issues were no longer present after the pcb underwent automated board level testing.The root cause of the difficulties experienced could not be identified.The problem condition can no longer be detected in the test device electronics.It is suspected that the problem condition was affected by exposing the test device to the conditions of automated board-level electrical test, however this could not be confirmed.The leads used were not returned for analysis, therefore, it could not be determined if they were damaged or contributed to the difficulties experienced.

Event Description

On july 9, 2016, it was reported that the patient's stimulation was off and she was unable to start the stimulation.The ipg would not connect to the cp.It was possible to charge with the ppc and the ipg showed 3 bars.After charging with the ppc, the connection between the cp and ipg was possible.The program was started and the patient felt the stimulation in the right spot.After a short period of time, the stimulation stopped when the patient moved.The impedances on both leads changed from normal to high.When the patient was not moving, all impedances were green.The patient was ok but without stimulation.On (b)(6) 2016, ipg, serial number (b)(4) was explanted and a new ipg was implanted.The leads were found to be in tact and are connected to the newly implanted ipg.There were no complications and patient is receiving therapy with the new ipg.

• 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 55499
• Manufacturer (Section G): NUVECTRA CORPORATION; 10675 naples street ne; blaine MN 55449
• Manufacturer Contact: amy parker ; 10675 naples stree ne; blaine, MN 55449 ; 7634047531
• MDR Report Key: 6139834
• MDR Text Key: 61289137
• Report Number: 3010309840-2016-00009
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2016
• Device Model Number: 2412
• Device Catalogue Number: 2412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 52 YR