MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37603

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Memory Loss/Impairment (1958); Neck Pain (2433)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medcal products: product id: 37603, serial#: (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 3387-40, lot# v001236, implanted: (b)(6) 2006, product type: lead.Product id: 748251, serial# (b)(4), implanted: (b)(6) 2006, product type: extension.Product id: 748251, serial# (b)(4), implanted: (b)(6) 2006, product type: extension.Product id: 3387-40, lot# j0337370v, implanted: (b)(6) 2006, product type: lead.(b)(4).

Event Description

Information was received from the patient that reported the patient's neck pain suddenly resurfaced in (b)(6) 2015 after being alleviated for 8 years.In addition, the patient had severe memory issues to the point where she would walk into a store and would not remember why she went in.She had been losing things in her house because she couldn't remember where she put them.The memory issues were gradual starting in (b)(6) 2015.The patient was implanted for dystonia and movement disorders.Further follow-up is being conducted to determine what steps were taken to resolve the neck pain and memory loss and had it been resolved.If further information is received, a follow-up report will be sent.**please see manufacturer report #3004209178-2015-17188 for information on the patient's concomitant system.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• 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: 5051448
• MDR Text Key: 25513155
• Report Number: 3004209178-2015-17190
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2015
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2015
• Date Device Manufactured: 03/10/2014
• 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 Age: 00066 YR