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 Problem Cognitive Changes (2551)

Event Date 01/24/2013

Event Type  Injury  

Event Description

It was reported the patient had perioperative delirium.The suspected cause was noted as the implant/study.There was no corrective action taken and the event resolved on (b)(6) 2013.

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, lot# serial# unknown, product type: extension.Product id: neu_unknown_ext, lot# 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.(b)(4).

Event Description

Additional information reported in was unknown if the delirium and increased fatigue were related to the implant procedure or study.The suspected cause was a patient condition.All symptoms were resolved.

• 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: 4653387
• MDR Text Key: 5682770
• Report Number: 3007566237-2015-00857
• 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: 06/17/2015

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: 04/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/09/2015
• 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