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

Model Number 3387S-40

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problems Dyspnea (1816); Headache (1880); Pain (1994)

Event Type  Injury  

Event Description

It was reported that there were wires left in the patient¿s brain because the healthcare professional had been afraid to remove them from the brain and it was causing the patient to not be able to breath correctly which was why he needed a continuous positive airway pressure (cpap) machine.The patient had very bad headaches.The patient¿s leads had started to make his head hurt.The leads gave the patient headaches that made migraines feel like nothing.The patient could feel the wire on the left side of his neck and stated that it was a long wire and the wire on the right was not as long as the wire on the left.The patient would get pain that started on the left side of the neck and then the pain spread to the right side of the neck and hits the forehead from temple to temple and then the pain attacked the eye so he would have to put on dark glass.No outcome was provided.Further follow-up is being conducted to obtain this information.If additional information is received a supplemental report will be submitted.Reference manufacturer¿s report number: 6000153-2015-00119.

Manufacturer Narrative

Concomitant products: product id 3387s-40, lot# va0ery5, implanted: (b)(6) 2014, product type lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type extension.(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: 4865089
• MDR Text Key: 5846829
• Report Number: 6000153-2015-00120
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• 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: 06/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2016
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA0CCDL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2015
• Date Device Manufactured: 09/21/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 00045 YR