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

Model Number 977A260

Device Problems Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 06/01/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 97714, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator.Product id 977a260, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.(b)(4).

Event Description

The consumer reported the lead moved, and the patient experienced variability in therapy relief.It was occurring intermittently.Re programming was tried to troubleshoot the issue.The patient fell, but it was after this issue started and no changes to therapy happened as a result of the fall.The patient was told he needs a revision.The patient did not have a health care provider (hcp) as he moved.Physician listings were given.The patient stated it was not working to relieve the pain.Medical history includes spinal pain.If additional information is received, a supplemental report will be submitted.

Event Description

Additional information was received from the patient.It was reported the patient was awaiting workman's comp approval for revision of the device.The patient would like reprogramming.They had tried reprogramming with the patient programmer but it did not stay in the right location.The patient was not feeling stimulation in the right spot and it was not working.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient stating that the lead had shifted down an inch and that they are still having problems with the implant.The patient requested reprogramming.The patient was instructed to contact their health care provider.No further patient complications have been reported as a result of this event.

Event Description

Additional information was received from a healthcare professional.It was reported that the x-ray confirmed lead migration.Lead reprograming and interrogation was tried and unsuccessful.The leads were going to be revised.No further complications were reported as a result of this event.

• Brand Name: VECTRIS SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5269366
• MDR Text Key: 32977689
• Report Number: 6000153-2015-00384
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2019
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2017
• Date Device Manufactured: 05/18/2015
• 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: 00047 YR
• Patient Weight: 104