MAUDE Adverse Event Report: REACTIV8 SYSTEM; REACTIVE PERCUTANEOUS STIMULATION LEAD

Model Number 8145

Device Problems Failure to Conduct (1114); Impedance Problem (2950)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2021

Event Type  Injury  

Manufacturer Narrative

If device is received, an evaluation is expected.

Event Description

It was reported that the patient was unable to initiate stimulation.Reportedly the stimulation lead electrodes were not functioning.Patient's surgeon decided to revise the complete reactiv8 system (stimulation leads, and implantable pulse generator).During revision surgery, the lead was damaged resulting in the distal three electrodes being unable to be explanted.The replacement system was successfully implanted to resolve the issue.

Manufacturer Narrative

Functional testing was performed on the returned implantable pulse generator (ipg).Ipg was found to be operating as intended.Visual inspection of the leads was performed due to device damage during explant.No fractures were observed on the first lead; functional testing was unable to be performed due to lead being cut during explant at the proximal end.Three fractured wires were observed on the second lead 390 millimeters from the proximal end.It is likely that the fractures were present for an extended period prior to explant because of the observed smoothness of the wire ends.The root cause of the reported out of range issue is the observed fractures.

• Brand Name: REACTIV8 SYSTEM
• Type of Device: REACTIVE PERCUTANEOUS STIMULATION LEAD
• MDR Report Key: 12608284
• MDR Text Key: 279630483
• Report Number: 3013017877-2021-00496
• Device Sequence Number: 1
• Product Code: QLK
• Combination Product (y/n): N
• PMA/PMN Number: P190021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/03/2021
• Device Model Number: 8145
• Device Catalogue Number: 8145
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other