MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37603

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

Patient Problems Bone Fracture(s) (1870); Seizures (2063); Injury (2348)

Event Type  Injury  

Event Description

It was reported that the patient had had seizure on two separate occasions post deep brain stimulator implant.Prior to the deep brain stimulator surgery the patient had never had a history of seizures.The first seizure had occurred on (b)(6) 2014 and the patient was taken to the hospital after the seizure where a computerized axial tomography scan (cat) was performed and nothing was found.The second seizure event occurred on (b)(6); the patient had a seizure and was taken to the hospital.While the patient was in the emergency room, she had another seizure when she had gotten up to walk to the restroom.The patient had smashed her face and broke her leg which had resulted in hospitalization and surgery on the leg.The patient was in physical therapy for two weeks.The patient is now on anti-seizure medication, keppra-anti which is an epileptic drug.It was noted that since the patient had started the drug she had not had another seizure.All seizure events had occurred while the deep brain stimulator was off, the patient had never been turned on.(b)(6) 2014 was the first time, the patient had stimulation turned on.The patient had unilateral implant on the left side for a right side tremor.Following programming on the date of this report there was no visible tremor and the deep brain stimulator was working fine.There was good tremor control.The patient was scheduled for a follow up appointment in two weeks from the date of this report.

Manufacturer Narrative

Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension.Product id: 3387s-40, lot# va0jfw2, implanted: (b)(6) 2014, product type: lead.(b)(4).

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• 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: 4062605
• MDR Text Key: 4853069
• Report Number: 3004209178-2014-16421
• 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
• Report Date: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2015
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2014
• Date Device Manufactured: 01/13/2014
• 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 Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 00064 YR