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

Model Number 2412

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 01/21/2016

Event Type  Injury  

Manufacturer Narrative

Device will not be returned to manufacturer for evaluation.A review of the device history record (dhr) is pending.Nuvectra is not able to submit this mdr due to issues with the portal set up process ((b)(4)) device not returned.

Event Description

Patient developed an infection 2 months post implant.The system was explanted.A new system was implanted and the patient is doing fine.

Manufacturer Narrative

Initial: device will not be returned to manufacturer for evaluation.A review of the device history record (dhr) is pending.Nuvectra is not able to submit this mdr due to issues with the portal set up process (ticket #s (b)(4)) follow-up/final: the source of the infection was not specified.The root cause for this event could not be determined as no device was returned for evaluation and review of the manufacturing records did not reveal any applicable discrepancies.No malfunction of the device could be confirmed.Device not returned.

Event Description

Patient developed an infection 2 months post implant.The system was explanted.A new system was implanted and the patient is doing fine.

• 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
• Manufacturer (Section G): NUVECTRA CORPORATION; 10675 naples street me; blaine MN 55449
• Manufacturer Contact: amy parker ; 10675 naples street ne; blaine, MN 55449 ; 7634047531
• MDR Report Key: 6139851
• MDR Text Key: 61291510
• Report Number: 3010309840-2016-00012
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/26/2016

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?: No
• Device Operator: Physician
• Device Expiration Date: 06/08/2017
• Device Model Number: 2412
• Device Catalogue Number: 2412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2015
• 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: 51 YR