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

Model Number 37603

Device Problems High impedance (1291); Low impedance (2285)

Patient Problems Headache (1880); Unspecified Infection (1930); Pain (1994); Tingling (2171); Complaint, Ill-Defined (2331); Deformity/ Disfigurement (2360); Numbness (2415); Neck Pain (2433)

Event Type  Injury  

Event Description

Additional information received reported it was unknown if there was a 50% or greater symptom reduction due to it being a new implant.The patient had stimulation induced dyskinesia which had just required reprogramming.The cause of the event was determined.The patient had recovered without permanent impairment.The patient had cervical dystonia.The patient was seen on (b)(6) 2014, it was noted that after stage 1 subthalamic nucleus (stn) deep brain stimulator electrode placement the patient had not noted a honeymoon period.Side effects had included a right incisional infection and headaches.The neck pain had remained unchanged and the patient had side effects of headaches.Following stage 2 implantable neurostimulator (ins) placement the patient had the right ins on and the patient had a decrease in neck pain and no change in speech.They were unsure if the head tremor was still present due to the patient still taking medication.The patient had left sided neck pain.Pain and posture prior to the deep brain stimulator at its worst was 20/10, average pain 8/10 and best pain 6/10.Since the deep brain stimulator the patient had worse pain, 10/10 with an average pain of 8/10 and best pain at 6/10.At the exam the patient¿s general appearance was normal, the patient was alert, oriented and their thought content was appropriate.The visit was for initial programming.Thresholds were checked.Right side programming had shown side effect was sensory, motor; tingling in bilateral palms and left back pulling for lead 1.For lead 2 side effect was sensory, motor; left arm numbness and tingling and pulling left shoulder.Lead 3 side effect was sensory motor; left hand numbness and tingling.There were no chronic side effects.The battery check had shown the battery at 3.12.Compliance was 99%.Right side therapeutic impedance readings at 3.0 volts were 0/c-20937, 1/c-1454, 2/c-674, 3/c-673, 0/1-20261, 0/2-21221, 0/3-21221, 1/2-1571, 1/3-1575 and 2/3-31.It was noted that based on the readings it appeared contact 0 was not functional.Patient¿s current setting was 2-c+, 1.4v, pw 90 and frequency 135.The patient had stimulation induced dyskinesia and was provided with group settings in hopes to avoid dyskinesia and provide benefit with dystonia.Right side had questionable function of contacts 0,2, and 3.The patient had stimulation with 2 and 3 and was having some improvement.The setting was changed to contact 1.The patient was going to return to the clinic in one month for further evaluation and management.Reference manufacturer¿s report number: 3004209178-2014-20426.

Manufacturer Narrative

Concomitant medical products: product id 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator; product id 3708660, serial# (b)(4), product type: extension; product id 3387s-40, lot# va0lln7, product type: lead; product id neu_ptm_prog, serial# unknown, product type: programmer, patient; product id 3708660, serial# (b)(4), product type: extension; product id 3387s-40, lot# va0jsnq, product type: lead; product id 3387s-40, lot# va0lln7, product type: lead; product id 3387s-40, lot# va0jsnq, product type: lead.(b)(4).(b)(4).(b)(6).

• 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: 4334136
• MDR Text Key: 5257606
• Report Number: 3004209178-2014-24050
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/24/2014

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: 01/28/2016
• 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: 11/24/2014
• Initial Date FDA Received: 12/16/2014
• Date Device Manufactured: 07/31/2014
• 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 Outcome(s): Required Intervention