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

Model Number	3777-60
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information references the main component of the system and other applicable components are:product id 37714, serial# (b)(4), product type implantable neurostimulator.
Event or Problem Description
Information was received via a manufacturing representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for other non-malignant pain and spinal pain.Information was reported that a patient had went to her pain doctor complaining of pain at an old incision site.There were no reported factors that may have closed this issue (falls, emi, patient compliance).An x-ray was taken of the area where she had pain and nothing abnormal seen.Surgery to explore cause of pain was done at site of previous incision.Scar tissue had developed around lead and this is what was thought to be causing pain.Scar tissue was removed.The issue had been resolved at the time of this report.No further complications were reported.No additional patient symptoms were reported.

• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): NEURO - VILLALBA; call box 6001; villalba PR 00766
• MDR Report Key: 6775093
• Report Number: 6000153-2017-00028
• Device Sequence Number: 18872601
• Product Code: LGW
• UDI-Device Identifier: 00643169157569
• UDI-Public: 00643169157569
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/18/2017
• Device Model Number: 3777-60
• Device Catalogue Number: 3777-60
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2017
• Initial Report FDA Received Date: 08/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR