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

Model Number 37601

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

Patient Problems Complaint, Ill-Defined (2331); Depression (2361); Cognitive Changes (2551)

Event Date 03/06/2013

Event Type  Injury  

Event Description

It was reported the patient had experiential phenomenon, depression, and illusions.No intervention was taken and the event was considered resolved.

Manufacturer Narrative

Concomitant products: product id 3387, lot # unknown, product type lead; product id 3387, lot # unknown, product type lead; product id neu_unknown_ext, serial # unknown, product type extension; product id neu_unknown_ext, serial # unknown, product type extension.(b)(4).

Manufacturer Narrative

Concomitant medical products: product id 3387s-40, lot# va01k4q, product type: lead.Product id 3387s-40, lot# v9 86836, product type: lead.Product id 3708660, serial# (b)(4), product type: extension.Product id 3708660, serial# (b)(4), product type: extension.The manufacturing site id was previously reported as #3007566237.Additional information indicates the correct manufacturing site id is 3004209178.

Event Description

Additional information reported the depression was not related to the device.It was unknown if the experiential phenomenon and illusions were related to the study and programming.One event of experiential phenomenon was unresolved.

• 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 MN 55421 120
• 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: 4658177
• MDR Text Key: 5603298
• Report Number: 3007566237-2015-00870
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2015

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: 12/14/2013
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/17/2015
• Initial Date FDA Received: 04/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/13/2015
• Date Device Manufactured: 06/18/2012
• 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): Other
• Patient Age: 00075 YR