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

Model Number 977A260

Device Problems Unintended Collision (1429); Therapy Delivered to Incorrect Body Area (1508); Malposition of Device (2616)

Patient Problems Nerve Damage (1979); Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 97714, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 3550-39, lot# n458894, implanted: (b)(6) 2014, product type: accessory.Product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 97754, serial# (b)(4), product type: recharger.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.(b)(4).

Event Description

The patient reported pain in both legs.The left leg was hurting more with arthritis since 2007.The right leg was hurting every day since 6 months ago.The change in therapy/symptoms was considered gradual.There were no product issues alleged.The indication for use was spinal pain.Additional information received from the patient reported their pain was from personal injury prior to implant.The device was implanted to treat the pain and now it has worsened in both legs and knees.Sometimes the pain in their knees brings the patient to tears.They were currently seeking out a new doctor but have not yet been able to schedule an appointment.They have already had too many mris and don't know if they will have another one.Additional information was received from the patient who had an implanted neurostimulator (ins) for spinal pain on (b)(6) 2015 stating that they were wanting the implantable neurostimulator (ins) removed and was looking for a doctor who could remove it.There was stimulation in the wrong location.The stimulator had been implanted to cover the lower back pain, which was covered, but they were also receiving stimulation from their knees to their hip and into their shoulder.The patient had tried to adjust stimulation, but they were never able to get it to cover only where it was needed.The patient stated that new pain and nerve damage had been created by the stimulation.More issues had been created because the patient was feeling stimulation in both knees and both shoulders.The patient stated that because the lead was implanted where it was and tied to the nerve that it was tied to, stimulation was creating pain in their knees and shoulders.They still felt the pain when the stimulation was off, and this issue had been gradually getting worse.They felt that the stimulation had caused nerve damage, which was why they felt pain with the stimulation off.A magnetic response imaging (mri) had been conducted, which only showed severe arthritis, and the patient's doctor had not specified that the knee and shoulder pain was caused by nerve damage by the stimulation or lead.A change in therapy had occurred after they had fallen.The patient was on a hill and fell, and that was the time they noticed the change in therapy.The stimulation in the wrong location and the fall had occurred in (b)(6) 2015, and the new pain and nerve damage had occurred in (b)(6) 2014.A supplemental report will be submitted if additional information is received.

Event Description

Additional information received from a healthcare provider reported that the last time they had seen the patient was on (b)(6) 2014.At that point the patient had not mentioned any nerve damage or stimulation issues.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received from the patient reported that the knee and shoulder pain started in (b)(6) 2015 and the patient was having trouble lifting their arms up to was their hair because of the pain.The patient had not used the ins since (b)(6) 2015 due to the pain.The patient had x-rays taken but they did not know the results of the x-rays.The patient had a doctor's appointment scheduled for 2016-(b)(6).

• 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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5366602
• MDR Text Key: 35966371
• Report Number: 6000153-2016-00106
• Device Sequence Number: 1
• Product Code: LGW
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2018
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/29/2016
• Date Device Manufactured: 06/11/2014
• 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: 00039 YR