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

Model Number 977A260

Device Problem Positioning Problem (3009)

Patient Problem Scar Tissue (2060)

Event Date 04/13/2016

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: neu_unknown_lead, product type: lead.Product id: 97714, serial# (b)(4), implanted: (b)(6) 2014, product type :implantable neurostimulator.

Event Description

The manufacturer's representative (rep) reported during a lead revision the original leads were removed, but the doctor was unable to implant the replacement leads.It was unknown what caused this, but the doctor speculated that over the years scar tissue had built up and created obstructions in the epidural space.It was noted an impedance test was also performed.The case was aborted with the implantable neurostimulator (ins) remaining implanted and the consumer was going to be set up for a paddle lead implant.Refer to manufacturer report #3004209178-2016-05956.Refer to manufacturer report #3007566237-2016-01937.

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 received from the healthcare professional (hcp) of a clinical study reported that the clinical diagnosis was lead placement aborted secondary to scar tissue.Interventions included surgical intervention specifically replacement of a previously explanted lead.

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 a health care provider (hcp) of a clinical study via a manufacturer representative (rep).It was reported that "lead 2" was explanted and not replaced.

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 MN 00766 1200
• Manufacturer (Section G): NEURO - VILLALBA; call box 6001; villalba,pr MN 00766 1200
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5647983
• MDR Text Key: 44993634
• Report Number: 3007566237-2016-01938
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2018
• 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: 04/14/2016
• Initial Date FDA Received: 05/11/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 11/17/2016
• Supplement Dates FDA Received: 10/27/2016; 12/12/2016; 09/22/2017
• Date Device Manufactured: 08/27/2014
• 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): Required Intervention
• Patient Age: 53 YR