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

Model Number 37612

Device Problem High impedance (1291)

Patient Problems Muscle Weakness (1967); Neurological Deficit/Dysfunction (1982); Seizures, Grand-Mal (2168); Twitching (2172)

Event Date 05/05/2014

Event Type  Injury  

Event Description

It was reported there was high impedance of >40,000.It was noted it was unknown what caused the high impedance.It was stated the patient was reprogrammed as a result of the event.It was noted the issue was not resolved.It was stated the patient status at the time of report was alive with no injury.It was noted the patient had seizures.It was noted they tried to reprogram around a lead electrode with high impedance and during the reprogramming the patient had experienced a seizure.It was noted the devices were implanted in an off label manner and use.It was noted the location of the issue was at the left side implant.It was further reported the high impedance did not resolve.It was clarified that this was not a deep brain stimulator (dbs) patient and it was a research patient who had paddle leads placed on their brain to provide epidural cortical stimulation to help treat depression.It was noted it was an off-label research.It was stated the patient was doing fine at the time of report and they left the hospital a short time after the seizure occurred.It was noted they returned to the hospital the next day and the doctor had turned their devices back on.Additional information received reported the patient¿s amplitude on (b)(6) 2014 was increased for a therapeutic delivery of approximately 13 uamps.It was stated the day prior to report the patient¿s mood was 85% of goal.It was noted they had no plans to change anything as the patient¿s mood particularly had turned around for the previous 2 days.It was stated that was until the doctor had seen 1 contact (11) in the right lateral paddle that consistently showed >40,000 for resistance which suggested an open contact.It was noted contact 11 was turned off.It was noted the configuration was changed in the paddle and the therapeutic delivery dropped from approximately 13 to 6.It was noted within minutes the patient began to have facial twitching and clonic movements in their upper extremities.It was noted the patient appeared to have a partial seizure in the doctor¿s office that had stopped within seconds of turning off the right system.It was stated both ins¿ were turned off and they had the patient transported to the emergency department.It was noted they appeared to have partial weakness in their left upper extremity and a facial droop postictal (todd¿s paralysis) that had resolved completely within minutes.It was stated by the time the patient was at the emergency department, they were completely asymptomatic.It was noted the head computed tomography scan (ct) was negative and their basic metabolic panel was within normal limits.It was stated the patient was discharged home.It was noted the patient was seen on the day of report and their mood was pretty good and they didn¿t have the lethargy that the patient had dealt with in the mornings for the past few months prior to report.It was noted the patient seemed to tolerate the current settings.It was stated the patient would be seen one week following report.It was noted the patient had arrived on the day of report without any sequelae.

Manufacturer Narrative

Concomitant products: product id 748951, serial# (b)(4), implanted: (b)(6) 2008, product type extension; product id 3986a, lot# n168427, implanted: (b)(6) 2008, product type lead; product id 3986a, lot# n169844, implanted: (b)(6) 2008, product type lead; product id 748951, serial# (b)(4), implanted: (b)(6) 2008, product type extension; product id 37651, serial# (b)(4), product type recharger; product id 37642, serial# (b)(4), product type programmer, patient; product id 3986a, lot# (b)(4), implanted: (b)(6) 2008, product type lead; product id 748951, serial# (b)(4), implanted: (b)(6) 2008, product type extension; product id 748951, serial# (b)(4), implanted: (b)(6) 2008, product type extension; product id 3986a, lot# n169844, implanted: (b)(6) 2008, product type lead; product id 37612, serial# (b)(4), implanted: (b)(6) 2012, product type implantable neurostimulator; product id 3986a, lot# n168427, implanted: (b)(6) 2008, product type lead; product id 3986a, lot# n168427, implanted: (b)(6) 2008, product type lead; product id 3986a, lot# n169844, implanted: (b)(6) 2008, product type lead.(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported over the course of several visits on (b)(6) 2014 the impedances were high but they were resolved at the time of report.It was stated on (b)(6) 2014 the impedances had normalized.It was noted the cause of the issue was not determined.It was stated at the time of report they were going to monitor and with reprogramming they had left that contact off.It was noted the patient had no sequelae from the high impedance and that event.It was noted the patient was doing well and appeared fine and they received effective therapy.It was stated they would monitor them for a return of high impedance but so long as the therapy remained effective they would leave contact 11 off until a series of visits continued to show the impedance had normalized.

• 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 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: 3835894
• MDR Text Key: 4453522
• Report Number: 3004209178-2014-09715
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2014
• 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): Other
• Patient Age: 00050 YR