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

Model Number 37601

Device Problems Low impedance (2285); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Type  Injury  

Event Description

It was reported that the patient was not able to adjust stimulation.There was a ¿call your doctor¿ icon displayed.There was an out of regulation (oor) condition.The oor message was seen on the patient programmer.It was noted that the patient had recently had a battery change.The patient was able to clear the oor message and check the device.It was further reported the cause of the event was unknown and the event was attributed to the implantable neurostimulator (ins).It was noted the ins may be needed to be ¿resynchronized¿ in the office.It was noted the patient was scheduled for a follow-up appointment for (b)(6) 2014 for reprogramming and to resynchronize the ins.It was stated the patient did not require hospitalization.Additional information received reported the patient had a loss of therapeutic effect.The patient was last seen near the (b)(6) 2014.They would use the programmer on the first of every month to check the implantable neurostimulator (ins).They had cleared the oor and moved on.Therapy impedance was unknown.Impedances were given as: c0 692 c1 1327 c2 1197 c3 589.It was noted they did not receive baseline impedances for the patient, only impedances after the ins change out.The device was estimated to hit end of service (eos) at 2.75 years approximately, but the patient¿s ins was already down to 2.73v.They only used the left side of their system ¿ the right side was inactive.The parkinson¿s disease symptoms appeared to get worse and the patient had gone from 3 to 4 sinamet a day.Four days later, it was reported they were going to see the patient and do more exhaustive measurements including the patient in multiple positions andre-testing.It did not go to oor in that time period on (b)(6) 2014.Multiple impedance checks were performed with the patient¿s head in different positions as well as while the lead/extension connector was palpitated and the ins header.They focused on c<(>&<)>0, as that was the used electrode configuration, and they found the following: impedances stayed in the 665 range when the patient¿s head was looking straight, to his right, and up.The impedances improved to 1150 range when the patient looked left, down, and when lead/extension connection and ins header were being palpitated.The cause of the impedance issue was not determined.They never saw impedance out of range when they checked it.Due to the battery drain, a suspected periodic short was the thought on c+, 0-.No lead fractures we re found.They programmed around the suspected short with the addition of two additional groups.They changed just the electrode configurations and kept all the other parameters the same (90pw, 180 rate, 3.9v).The patient tolerated both group b and c and they seemed to do well.They would check the device daily and report any oor messages or loss of efficacy.

Manufacturer Narrative

Concomitant medical products: product id: 3389s-40, lot# v402883, implanted: (b)(6) 2010, product type: lead.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 37092, lot# 240620002, implanted: (b)(6) 2010, product type: accessory.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension.(b)(4).Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.

Manufacturer Narrative

Analysis of the implantable neurostimulator (s/n (b)(4)) found no significant anomaly, the ins battery was not in new condition.

Event Description

Additional information received reported the implantable neurostimulator (ins) was explanted due to rapid battery depletion and it was not normal.The patient outcome was not reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 4170622
• MDR Text Key: 17996851
• Report Number: 3004209178-2014-19655
• 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: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2014
• 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
• Patient Age: 00077 YR