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

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 07/13/2016

Event Type  Injury  

Manufacturer Narrative

Due to limited information and the absence if any unique identifiers, no investigation can be conducted.Regarding the statement about the software/firmware error, there have been 2 field actions initiated, both have been reported to the fda per 21 cfr part 806.Reference fda recal numbers z -1192-2016 through z-1194-2016 and z -1600-2016.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 (ticket #s (b)(4)).Device not returned to manufacturer.

Event Description

A report was received through the fda's medwatch program (mw5064075).The report was forwarded to nuvectra and received by nuvectra on (b)(6) 2016.The report states, "the lead used with algovita scs device made by nuvectra broke apart and fragments remain in the pt's body.Happened twice on 2 different leads.Also, there is a software/formware error in algovita scs that may result in catastrophic failure of implanted device known to company but perhaps not reported.".

• 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: anne reali ; 10675 naples stree ne; blaine, MN 55449 ; 7634047508
• MDR Report Key: 6139651
• MDR Text Key: 61290644
• Report Number: 3010309840-2016-00010
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/25/2016

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
• Date Manufacturer Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention