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

Model Number 977A260

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Unspecified Infection (1930); Staphylococcus Aureus (2058); Sepsis (2067); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Date 09/26/2014

Event Type  Death  

Manufacturer Narrative

(b)(4).Continuation: product id 97714, serial# (b)(4), implanted: 2014-(b)(6), explanted: 2015-(b)(6), product type implantable neurostimulator.Product id 977a260, serial# (b)(4), implanted: 2014-(b)(6), explanted: 2015-(b)(6), product type lead.(b)(4).

Event Description

The consumer reported they had the worst year of their lives.There was an infection at the patient's spine.The leads at the bones where the leads were attached and the patient was still taking antibiotics.They had to put in 2 rods and screws to replace the bones where the leads were.From the beginning, the manufacturer's representative (rep) and healthcare provider (hcp) had told them they needed to turn the stimulation up and that the patient had to walk more.They had to see a thoracic surgeon to have the device removed.At the time of the report, they were still seeing an infectious disease doctor.They had not sent the device for analysis and they picked it up from pathology in the hospital where it was removed.It never helped with the lower back pain which was why they originally had the device and ended up causing severe upper back pain.Because of this, the patient suffered seizures and could not walk.This was noted to be a nightmare from hell.The consumer noted they told the hcp it was oozing at the location of the implantable neurostimulator (ins) and he said there was nothing wrong with it.So, they went to the family hcp and had a culture done and it came back that it was full of staph.Now, the patient had to have physical therapy to walk.There was a staph infection at the upper spine and ins location that occurred suddenly in (b)(6) 2015.They system was explanted.Relevant medical history included spinal pain.Please see manufacturer report #3004209178-2015-24822 for information on the patient's concomitant product.

Manufacturer Narrative

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

Event Description

Additional information was received from the consumer who reported the patient ¿contracted sepsis¿ at the hospital at the time of their implant surgery.The sepsis weakened the patient¿s organs and heart and they ultimately died.Additional information received from the healthcare provider (hcp) reported the patient never followed up with them and the last time they saw them was on (b)(6) 2014.On (b)(6) 2015 the patient saw another physician who removed the infected spinal cord stimulator.On (b)(6) 2016 the patient had an emergency room visit.Following this the patient had a full arrest and died.According to the physician there was no device, therapy, or procedure issue that may have caused or contributed to the patient¿s passing, but suggested to follow-up with the physician who saw the patient on (b)(6) 2015.All additional information received regarding this event will be reported under regulatory report #3004209178-2015-24822.

Manufacturer Narrative

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

• 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: 5285913
• MDR Text Key: 33242853
• Report Number: 6000153-2015-00450
• 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: consumer,health professional
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2018
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/10/2015
• Supplement Dates Manufacturer Received: 06/18/2018; 08/08/2018
• Supplement Dates FDA Received: 07/17/2018; 10/05/2018
• Date Device Manufactured: 09/03/2014
• 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): Death; Other; Required Intervention
• Patient Age: 00060 YR