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

Model Number 3387S-40

Device Problems Bent (1059); Shipping Damage or Problem (1570); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2015

Event Type  malfunction  

Event Description

It was reported that when the doctor opened all three leads, the ¿straw¿ that protected the lead in the box was bent and curved, thus bending the stylet inside the lead.The doctor was concerned and tried three total leads and all were bent.The doctor eventually found one without the bend in it.The three leads were not implanted.The patient was alive with no injury or adverse event.Refer to manufacturing report #6000153-2015-00114 and #6000153-2015-00115 as three leads were found to be bent and rejected.

Manufacturer Narrative

Concomitant medical products: product id 3387s-40, lot# va0u2l4, product type: lead; product id 3387s-40, lot# va0u2l4, product type: lead; product id neu_stylet_acc, product type: accessory; product id neu_stylet_acc, product type: accessory; product id neu_stylet_acc, product type: accessory.(b)(4).

• 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: 4859756
• MDR Text Key: 5846131
• Report Number: 6000153-2015-00116
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2017
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA0U2L4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2015
• Date Device Manufactured: 03/19/2015
• 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: 00073 YR