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); Device Or Device Fragments Location Unknown (2590)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 12/22/2015

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 patient reported via the manufacturer representative (rep) that the implantable neurostimulator (ins) was turning off by itself.The patient would lose stimulation when it turned off.The patient was also getting stimulation in a different location (ribs and shoulder blades) than before.The rep suspected that the lead had migrated.The patient was able to get good coverage on the other lead.No trauma/falls were related.Both the shutting off and the stimulation in the wrong location occurred on the same day.The device was turning on/off.Additional information received from the rep in response to follow-up reported that no further information was known.The patient had been instructed to contact the rep if the problem continued and they hadn't been contacted by the patient.Additional follow-up was performed to determine what actions were taken to address the event and if it was resolved.Relevant medical history included non-malignant pain.

Event Description

Additional information received from the healthcare provider via the manufacturer's representative (rep) reported the consumer felt stimulation in the abdomen.An x-ray was ordered which showed the leads had migrated up.The leads were revised on (b)(6) where the physician opened the spine incision only and pulled the leads down and re-anchored them with sutures.Following the revision the issue was resolved.

Event Description

Additional information was received from the patient.It was reported that the steps taken to resolve the issue was that they set up and tried new programs.The issue had not yet resolved, but was still being working on.

Manufacturer Narrative

Continuation of concomitant 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.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient.It was reported that the patient had the ins removed in 2017 because it was not helping with pain and it was sending a "pulsing" sensation to their stomach.The patient stated that the leads were left in and they were having a different ins put in but they needed to do a mri first.No further complications were reported/anticipated.

• 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 ; 7635263987
• MDR Report Key: 5368072
• MDR Text Key: 36343174
• Report Number: 6000153-2016-00117
• 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,Followup
• Report Date: 06/27/2018

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: 06/12/2019
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/26/2018
• Date Device Manufactured: 06/12/2015
• 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: 00052 YR