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

Model Number 399930

Device Problems Migration or Expulsion of Device (1395); Human-Device Interface Problem (2949)

Patient Problems Nerve Damage (1979); Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Shaking/Tremors (2515)

Event Date 08/01/2012

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 37712, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator.Product id: 37712, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator.Product id: 3776-60, serial# (b)(4), product type: lead.Product id: 3999, lot# j0546605v, product type: lead.(b)(4).

Event Description

A patient implanted for other chronic/intract pain (trunk/limbs), other upper quadrant sites, and spinal pain reported she heard there was a new device that could provide stimulation without the stimulation sensation, and wanted that one instead.The manufacturer's representative (rep) told her she could have that with her existing device so she went to the healthcare provider (hcp) for high definition programming to be added.After having the high definition programming added it suddenly made her feel sick and caused goofy things in her head and body.The patient stated the rep.Told her if she didn't like the hd programming she could go back to program a, but she couldn't get it back to program a, and didn't want to mess with it anymore for fear of losing programming.No interventions or outcome were reported related to this event.Additional information has been requested.If additional information is received the event will be updated.Additional information was received from the patient on (b)(6) 2016 stating that the patient "played with things and got it started".It was still not the way it had been, but it would never be if the leads were not where they were put, as they had moved.The patient's doctor had told them that the leads could not move.A supplemental report will be submitted if additional information is received.

Manufacturer Narrative

References the main component of the system and other applicable components are: product id 37712, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator.Product id: 37712, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator.Product id: 3776-60, serial# (b)(4), product type: lead.Product id: 3999, lot# j0546605v, product type: lead.This event in regards to the other leads was reported in mdr # 6000153-2016-00505 and 6000153-2016-00508.

Event Description

Additional information was reported by the consumer on (b)(6) 2017 that a repair surgery occurred in (b)(6) 2012 which was not repaired correctly because the hcp clamped it on the outside of their spine which would not hold.Their current leads were causing trouble with the patient¿s nerves because they had moved and were not where they were supposed to be.X-rays and as associate said that it moved and the patient was going to need surgery soon to get it back where they needed it.Their legs were at the point where they were completely gone.In the morning the patient¿s spouse had to help and put patched on which took 3-4 times to get up in the morning.The patient was looking for a new health care professional (hcp).The consumer called back on (b)(6) 2017 but no new information regarding this event was provided.The patient called back on (b)(6) 2017 but no new information regarding this event was provided.

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 consumer on (b)(6) 2017 reporting that they were calling in regards to the patient letter that they received.Hcp listings were requested and provided.It was reported that their primary care physician diagnosed them with lupus 6 months ago and referred them to a rheumatologist who told the patient they were a slight positive for lupus and had worse issues going on.This was clarified to mean the patient¿s tremors.The caller reported that their ¿nerves were shaking¿ and that ¿this thing in [their] back was causing extra damage to the nerves.¿ the current leads had not been in the right place for a ¿long, long time.¿ the leads were not where they were supposed to be and the patient felt them move.

• Brand Name: SPECIFY
• 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: 5444217
• MDR Text Key: 38994233
• Report Number: 6000153-2016-00506
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2012
• Device Model Number: 399930
• Device Catalogue Number: 399930
• Device Lot Number: V173396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2017
• Date Device Manufactured: 11/06/2008
• 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: 66 YR