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

Model Number 977A260

Device Problems High impedance (1291); Unable to Obtain Readings (1516); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id 97714, serial # (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2016, product type implantable neurostimulator; product id 977a260, serial # (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2016, product type lead.(b)(4).Analysis of the lead (serial # (b)(4) found that the stimulation lead body conductor was broken due to overstress or damage.Only a segment of the proximal end of the lead was returned for analysis.

Event Description

The patient via a manufacturer representative reported that the patient¿s leads had failed.The patient was seen in office by a manufacturer representative where it was noted that the unit wasn¿t working and the leads had stopped functioning and when the impedances were checked they were all over 10,000 ohms.It was also noted that the impedances showed as ¿xxx¿ so it was unclear which elect rodes had impedances >10,000 ohms and which ones showed ¿xxx¿ impedance readings.The patient was taken for a lead revision and the leads and implantable neurostimulator (ins) were replaced.The issue was considered resolved at the time of the report.The patient status was listed as ¿alive ¿ no injury¿ at the time of the report.The patient was implanted for spinal pain.

Manufacturer Narrative

The analysis results were corrected.Updating analysis summary: (b)(4).Analysis of the lead (serial # (b)(4)) found that the stimulation lead body conductor was broken but the anchor site was un known.Wires 0 through 6 were broken 20.2 centimeters from the distal end.

• 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: 5418049
• MDR Text Key: 37718361
• Report Number: 6000153-2016-00382
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2017
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2013
• 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: 00056 YR