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

Model Number	387360
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product id: neu_stylet_acc, serial# unknown, product type: accessory.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.
Event or Problem Description
The healthcare professional (hcp) via the manufacturer representative reported that the trial lead was unable to advance through the touhy needle.Stylets were swapped to troubleshoot but were unsuccessful.Needle angle was rechecked and loss of resistance rechecked.A new trial lead was opened and advanced without trouble.The issue was resolved at the time of the report.No surgical intervention occurred or was planned.The patient¿s status at the time of the report was alive-no injury.Additional information received from the manufacturer representative reported that the lead had been returned for analysis.
Additional Manufacturer Narrative
Analysis of the lead, lot # va19ndg, found no anomaly.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: STANDARD TRIAL LEAD
• 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: 6166151
• Report Number: 6000153-2016-00824
• Device Sequence Number: 876018
• Product Code: LGW
• UDI-Device Identifier: 00643169157385
• UDI-Public: 00643169157385
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/15/2020
• Device Model Number: 387360
• Device Catalogue Number: 387360
• Device Lot Number: VA19NDG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2016
• Initial Date Received by Manufacturer: 11/16/2016
• Supplement Date Received by Manufacturer: Not provided; 12/27/2016
• Initial Report FDA Received Date: 12/12/2016
• Supplement Report FDA Received Date: 01/18/2017; 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR