MAUDE Adverse Event Report: NEURO - VILLALBA ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 3389S-40

Device Problems Bent (1059); Shipping Damage or Problem (1570)

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

Event Type  malfunction  

Event Description

It was reported that upon removal from the sterile package, the healthcare professional had noticed that the 0 contact by the lead tip was bent.The lead was not implanted and another lead was opened and implanted.No diagnostic testing or troubleshooting was done or required.The issue was resolved but the cause was not determined.

Manufacturer Narrative

Product id: neu_stylet_acc, serial# unknown, product type: accessory.(b)(4).Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Manufacturer Narrative

Product analysis #(b)(4):the distal end of the lead is bent at the #0 electrode.It appears to be caused by the stylet pushing against the distal tip of the lead.Concomitant medical products: product id neu_stylet_acc, serial# unknown, product type: accessory.Analysis of the lead found the distal end was bent at the #0 electrode, out of the box.It had appeared to be caused by the stylet pushing against the distal tip of the lead.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 4272160
• MDR Text Key: 5029358
• Report Number: 6000153-2014-00199
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2017
• Device Model Number: 3389S-40
• Device Catalogue Number: 3389S-40
• Device Lot Number: VA0PDV4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2014
• 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