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

Model Number 3389S-40

Device Problem Low impedance (2285)

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

Event Date 08/22/2014

Event Type  malfunction  

Event Description

It was reported that the patient had a lead with a short circuit.The patient only had leads implanted and was going to have the implantable neurostimulator (ins) the following friday.The impedances were checked during the procedure and they saw a short on 0-3 combinations.They changed out the lead and this resolved the issue.There were concerns that the cause of the short was due to the lead being tightened down too hard on the microdrive.Eight days later information was received indicating that it was unknown what caused the short.The entire lead was removed and replaced with another lead.Impedances were checked twice prior to replacing the lead.The patient was doing well at the time of the report.

Manufacturer Narrative

Concomitant medical products: product id: 3389s-40, lot# va0llnh, implanted: (b)(6) 2014, product type: lead.(b)(4).

Manufacturer Narrative

Concomitant medical products: product id neu_stylet_acc, product type: accessory.Additional analysis of the lead, lot #va0lryy, found the body¿s outer insulation damaged at the depth stop site.Impressions from over-tightening of the depth stop were observed on the outer insulation of the lead, 8.2 centimeters from the proximal end.

Manufacturer Narrative

Analysis of the lead (lot # va0lryy) found no anomaly.

• 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: 4092670
• MDR Text Key: 4713400
• Report Number: 6000153-2014-00165
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2017
• Device Model Number: 3389S-40
• Device Catalogue Number: 3389S-40
• Device Lot Number: VA0LRYY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2014
• 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
• Patient Age: 00074 YR