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

Model Number 37602

Device Problems Unexpected Therapeutic Results (1631); Radiofrequency Interference (RFI) (2314); Device Displays Incorrect Message (2591)

Patient Problems Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Shaking/Tremors (2515)

Event Type  malfunction  

Event Description

It was reported that the patient experienced a loss of therapeutic effect following an implantable neurostimulator (ins) replacement.It was noted that the patient felt ¿ever since the replacement, her tremor control is not as good.¿ the patient had a ¿major problem¿ and had a new implantable neurostimulator (ins) implanted on (b)(6) 2012.The patient had good results with the previous ins and tremors had stopped, the patient had been pretty well stabilized.Following implant of the newer ins the patient had never had a day without the shakes or tremors since the implant.The patient had regular trips to their healthcare professional prior to moving 4 months ago but never gotten any satisfaction with the ins that been implanted on (b)(6) 2012.The patient moved to alaska 4 months prior to the date of this report and the device been turned off since then because it did not make any difference if it was on or off as far as the patient¿s reflexes.The battery was now up to 3 years old.The patient star ted out with the deep brain stimulation 5 years prior to (b)(6) 2012 and had good results with the basic simpler model than the new one.The patient not good results with the newer ins even though it more expanded options or coverage.The device was not providing the patient any therapeutic relief.It was later reported that the patient was seeing an 8380 error message on the patient programmer.The patient was also seeing 3.8v on the screen.The patient been in to see their healthcare professional several times since the implant in an attempt to improve therapy.The therapy not worked like it used too and the healthcare professional turned the device off about 6 months prior to the date of this report.Additional information received reported the patient¿s essential tremor gotten worse after the implantable neurostimulator (ins) replacement.When the patient turned their stimulation off their essential tremor was worse.The manufacturing representative believed the patient¿s essential tremor was due to progression of their condition and stress from moving.The patient moved to alaska and was currently looking for a healthcare professional.The manufacturing representative also clarified the patient was on group a at 3.80v.The patient¿s implant not been working since getting it replaced and the patient had nothing but issues since then.They been struggling and the patient been unable to use the stimulation system.The patient not a good day since replacement.The battery was replaced in 2012 and they were going nowhere.Patient stimulation on the right side but was not getting symptom relief for the tremors.They made 20 trips for programming but it not resolved the issue.The problem was because of a defective device.The patient last been seen by their healthcare professional about a year prior to the date of this report and they been without a device since then.It was noted that it was useful if they could find relief with programming.The patient could feel stimulation but it was not helping the patient anymore and the patient still tremors.Patient an appointment with their psychologist¿s office the week following (b)(6) 2015 to meet with a manufacturing representative.

Manufacturer Narrative

Concomitant medical products: product id 37642, serial# (b)(4), product type: programmer, patient; product id 3387s-40, lot# v013793, implanted: (b)(6) 2007, product type: lead; product id 748251, serial# (b)(4), implanted: (b)(6) 2007, product type: extension.(b)(4).

Manufacturer Narrative

Analysis of the neurostimulator, serial #(b)(4), found the battery at normal end of life.The telemetry and output were okay.There were no significant anomalies.

Event Description

Additional information received reported that since the patient's last implantable neurostimulator (ins) was replaced, their symptoms had worsened and their tremor had never been as well controlled.The patient's healthcare professional (hcp) stated the patient's symptoms had been progressing a bit and they only had a unilateral implant, but the tremor was on the other side as well.The patient thought there was a problem with the battery.When the ins was off, the patient's symptoms were really bad.There were no impedance issues and nothing that indicated that there was a problem.The reporter did not believe there was a problem with the battery.Despite normal impedances and multiple attempts to reprogram, the patient was still unhappy.An elective replacement indicator (eri) message due to normal battery depletion had been displayed.The ins was replaced and there was no patient death or injury.

• 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: 4632873
• MDR Text Key: 5754672
• Report Number: 3004209178-2015-05408
• 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: Consumer,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2013
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2012
• 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 Age: 00081 YR