MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

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

Patient Problems Edema (1820); Encephalopathy (1833); Seizures (2063); Irritability (2421); Cognitive Changes (2551); Confusion/ Disorientation (2553); Test Result (2695)

Event Date 03/14/2015

Event Type  Injury  

Event Description

It was reported that the patient had acute delirium.Signs and symptoms included verbal agitation, confusion, encephalopathy and slight seizure activity.It was noted that the surgery/anesthesia was possibly related to the device or therapy and it was possibly related to implant procedure.The event had resulted in in-patient hospitalization and seizure medication.Lab work results were negative for an infection.Electroencephalogram (eeg) results indicated no seizure, no rhythmic or periodic patterns, intermittent bursts of generalized delta activity with slow posterior dominant rhythm (pdr).A computerized tomography (ct) scan without contrast results indicated edema in the superior right frontal lobe.The outcome was resolved without sequelae.

Manufacturer Narrative

Concomitant products: product id: 3387s-40, lot# va0q81g, implanted: (b)(6) 2015, product type: lead.Product id: 3387s-40, lot# va0q81g, implanted: (b)(6) 2015, product type: lead.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension.(b)(4).(b)(6).

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; 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: 4771432
• MDR Text Key: 5779142
• Report Number: 3004209178-2015-09096
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2015
• Date Device Manufactured: 09/04/2014
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 00051 YR