MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37603

Device Problems Electromagnetic Interference (1194); High impedance (1291)

Patient Problems Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Neck Stiffness (2434)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3387s-40, lot# v763711, implanted: (b)(6) 2011, product type: lead.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension.Product id: 3387s-40, lot# v763711, implanted: (b)(6) 2011, product type: lead.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension.(b)(4).

Event Description

The consumer reported that there were having strange sensations, tension in the neck, and a return of symptoms.The patient went through a full body scan at the airport and knew right away that she should not have done that.She immediately felt that something was different.Right away after the body scan, she began to have strange sensations.Her legs and torso felt cold, which would last for about 5 minutes and then would go away for 20 min and then return.This continued to come and go.There was also tension in the neck, which was a return of symptoms.This was later in the day after the full body scan at the airport.She had tension in the neck, which was a pinching she got from her dystonia.The manufacturer representative (rep) met with the patient and verified that the stimulation was currently on.The rep said the impedance level was extremely high.The rep rebooted the right side and the patient stated that they did not feel much different.When the rep rebooted the left side, the pinch in her neck went away.This was considered a sudden change in therapy/symptoms.The indication-for-use (ifu) was dystonia and movement disorders.No outcome or intervention was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• 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: 5198833
• MDR Text Key: 30532915
• Report Number: 3004209178-2015-22125
• 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
• Type of Report: Initial
• Report Date: 10/13/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2014
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/13/2015
• Initial Date FDA Received: 11/03/2015
• Date Device Manufactured: 02/20/2013
• 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: 00071 YR