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

Model Number 977A260

Device Problem Shipping Damage or Problem (1570)

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

Event Date 01/30/2015

Event Type  malfunction  

Event Description

It was reported that there was a packaging or package label problem; the components were not packaged properly.The issue was encountered when the brand new device was opened.It was indicated that the box was totally intact.However, when they went to pull the paper sheath from the plastic tray the product sits, the plastic cracked and came off with the paper sheath.They were concerned about product sterility.It was decided that the product would not be used and the product was never used on a patient.They didn't even attempt to use it.No patient injury was reported.A follow-up report will be sent should additional information be received.

Manufacturer Narrative

(b)(4).

Event Description

It was later reported that it is planned to return the device to the device manufacturer.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Manufacturer Narrative

Device analysis for lead va0qwaf007 revealed the packaging was damaged.One end of the outer tray is broken with the broken edge still stuck to the tyvek lid.The opposite corner of the outer tray is also bent with a crease in the tyvek lid.This indicates that the bending and breakage of the outer tray occurred after the tyvek lid had been sealed to the tray.

Event Description

It was additionally reported that the circulating nurse opened the of box of the lead and pulled the top cover off the lead to hand it over to the scrub tech on sterile field.Before handing the box over, it was noticed the plastic on the cover of the lead was broken so it was not used or implanted.No patient injury reported.

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 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: 4484198
• MDR Text Key: 5497864
• Report Number: 6000153-2015-00025
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2018
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2014
• 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