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

Model Number 37601

Device Problem Failure to Deliver Energy (1211)

Patient Problems Emotional Changes (1831); Cognitive Changes (2551)

Event Type  Injury  

Event Description

It was reported the patient had an altered mental status, specifically a manic episode.It was reported that there were no alleged product issues, no troubleshooting was performed, and no action was required as a result of the event.It was reported the patient¿s status was unable to be obtained at time of this report.Additional information received reported that hospitalization was required as a result of the event.The patient outcome was serious life-threatening illness/injury recovered without sequelae.The symptoms associated with the reported event included mania.The cause of the event was unknown.It was unknown if the event was due to the implantable neurostimulator (ins) or the lead/extension.It was noted that next to reprogramming ¿device turned off¿ was written.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Product id: 3387s-40, lot# va05qgb, implanted: (b)(6) 2013, product type: lead.Product id: 3708695, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.Product id: 3708695, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.Product id: 37642, serial# (b)(4), product type: programmer.Patient product id: 3387s-40, lot# va074jr, implanted: (b)(6) 2013, product type: lead.(b)(4).

Manufacturer Narrative

(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: 3622600
• MDR Text Key: 4135225
• Report Number: 3004209178-2014-02800
• 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,Followup,Followup
• Report Date: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2013
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2014
• Date Device Manufactured: 06/27/2012
• 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; Life Threatening
• Patient Age: 00065 YR