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

Model Number 977A260

Device Problems Break (1069); Difficult to Insert (1316); Positioning Problem (3009)

Patient Problem Adhesion(s) (1695)

Event Date 04/17/2014

Event Type  malfunction  

Event Description

It was reported that during the trial implant procedure, the hcp experienced difficulty inserting the lead.When the lead approached the target site, there were difficulties due to ¿severe adhesion¿ in the epidural space.It was also noted that when advancing the lead while replacing the stylet and applying torque, the stylet replacement ¿became harder¿ and could not be fully inserted.The electrodes were replaced with new one and the lead was inserted successfully.It was also stated that when the excessive torque is applied, ¿the main unit of the electrodes is distorted¿ and results in a narrowed space for stylet insertion.It was reported there was no health hazard to the patient.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Analysis of the lead found the stylet coil of the lead body had foreign material blocking stylet insertion.It was noted analysis of the stylet (s/n unknown) found not significant anomaly.It was noted the stylet wire was bent.Analysis of the stylet (s/n unknown) found not significant anomaly.It was noted the stylet wire was bent.

• Brand Name: VECTRIS
• 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: 3803292
• MDR Text Key: 4370771
• Report Number: 6000153-2014-00088
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2014

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: 11/01/2017
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2014
• Initial Date FDA Received: 05/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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