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

Model Number 3389S-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seizures (2063)

Event Type  Injury  

Manufacturer Narrative

Generalized seizure activity.Concomitant products: product id 3389s-40, lot # va09wn5, implanted: (b)(6) 2013, product type lead.(b)(4).

Event Description

It was reported that after the patient¿s leads were placed the ¿subject started having generalized seizure activity.¿ it was noted the patient was then started on an intravenous antiepileptic drug on (b)(6) 2013.A ct scan of the patient¿s head was performed.The ct scan was ¿negative¿ and indicated the ¿lead placement was correct.¿ it was noted the patient resolved without sequelae on (b)(6) 2013.It was stated the generalized seizure activity ¿resulted in in-patient hospitalization,¿ ¿prolonged existing hospitalization,¿ and ¿resulted in persistent or significant disability/incapacity.¿ a supplemental report will be filed if additional information is received.

• 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: chad hedlund ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149619
• MDR Report Key: 3565365
• MDR Text Key: 19399046
• Report Number: 6000153-2014-00005
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2016
• Device Model Number: 3389S-40
• Device Catalogue Number: 3389S-40
• Device Lot Number: VA09WN5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2013
• Initial Date FDA Received: 01/09/2014
• Date Device Manufactured: 06/10/2013
• 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): Hospitalization; Other; Disability