MAUDE Adverse Event Report: NEURO - VILLALBA VECTRIS SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 977A260

Device Problems Malposition of Device (2616); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Burning Sensation (2146)

Event Date 12/21/2015

Event Type  Injury  

Manufacturer Narrative

A manufacturer¿s report was sent on both implantable leads as it was unclear which lead applied to the reported issues.Concomitant medical products: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.(b)(4).

Event Description

The consumer and healthcare professional via the manufacturer representative reported that the patient was only feeling stimulation on one side.The consumer and healthcare professional also reported that they looked at the lead under x-ray at several different angles, and it was believed that the lead was not implanted deep enough.During implant, the leads were placed according to pictures taken during the trial.At follow up, the implant pictures and trial pictures were identical, and it was determined that one lead was not deep enough when a lateral x-ray image was taken.It was noted that the manufacturer representative turned on stimulation post-operatively, and the patient had verified that he could feel it.The reported issue was not resolved at the initial time of report, and the patient's status was alive with no injury.It was further reported that lead revision was planned for (b)(6) 2016.It was noted that the manufacturer representative would obtain further event information from the healthcare professional on (b)(6) 2016.Further follow up is being conducted to obtain this information.If additional information becomes available, a follow up report will be sent.The patient's indications for use included non-malignant pain.

Event Description

Additional information noted that the patient was very happy with their therapy since the revision.He has no complaints at this time.

Event Description

Additional information was received from the patient.It was reported that the healthcare professional (hcp) put the leads in wrong the first time so they had to do a revision.The leads were implanted too close to the surface of the skin and when the patient turned stimulation on it felt like it was burning his skin.The patient had the revision and the leads were now deep enough but he still had no therapeutic benefit.The patient never had therapeutic benefit.The patient met with manufacturer representatives (reps) two or three times for reprogramming but still didn¿t really have therapeutic benefit, though it was hitting the right spot.The last time the patient met with a rep he told the patient that two of the electrodes on the leads were broken.The patient was told that the leads were backwards and upside down.It was noted that the patient had no falls or trauma.The patient planned to have the device explanted.The patient was redirected to follow-up with the hcp to discuss symptoms.It was noted that the patient met with a rep in (b)(6) 2016.It was also noted that he patient may discuss with his managing hcp to find another surgeon to remove the device.Refer to mfr report #6000153-2016-00592 for the report of this event for one of the patient's other leads.

• Brand Name: VECTRIS SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): NEURO - VILLALBA; call box 6001; villalba PR 00766
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5457955
• MDR Text Key: 38960323
• Report Number: 6000153-2016-00591
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2019
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2016
• Date Device Manufactured: 07/21/2015
• 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): Required Intervention
• Patient Age: 00048 YR