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

Model Number 37601

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Muscular Rigidity (1968); Swelling (2091); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that there was a loss of efficacy which was unrelated to stimulation therapy.Patient¿s current battery voltage was 2.66v.In the past few months prior to the date of this report, the patient had been having issues with freezing and gate issues.A longevity calculation was performed to estimate the battery life of the implantable neurostimulator (ins).Based on the current settings the ins would last 9.5 months and the patient was implanted 18 months prior to the date of this report.There was 100% usage.There were no known falls or traumas.The patient used a walker and may have fallen and not reported.The ins had seemed to be moving further down.It was unknown if it was loose in the pocket as it was sutured to fascia.The patient was in the hospital for the past few days prior to the date of this report which involved some anxiety along with other possible deep brain stimulator related issues, stiffness and ankle swelling.Patient had contacted the healthcare professional in (b)(6) to be seen, patient was seen on (b)(6) 2014.Healthcare professional had requested patient come back in for more diagnostic testing before replacing the ins.Patient had control but could not tolerate the increased amplitude.The patient was trying to increase to alleviate the freezing and gate issues.Patient¿s current settings were 5.1v amplitude, rate was 170hz, pulse width was 90 and impedance was 1630 ohms.It was later reported patient had recently had some medical symptoms which were concerning but which may not be related to the deep brain stimulator therapy.Extensive impedances were run and all impedances were normal.Program 1 was at 5.0v, 90pw, 170hz, and 1033 ohms.Program 2 was at 5.1v, 90pw, 170hz, and 1611 ohms.It was noted that at those parameters, the ins would last about 19.19 months.The ins seemed to be at the appropriate charge level based on the information.There was no longevity complaint.Patient was having an mri and it was part of the medical work up and they did not suspect deep brain stimulator failure/malfunction considering the longevity estimate.

Manufacturer Narrative

Product id neu_unknown_ext, serial# unknown; product type extension product id 3387s-40, lot# v184846; product type lead product id 37642, serial# (b)(4); product type programmer, patient product id 3708660, serial# (b)(4), implanted: 2013 (b)(6); product type extension.(b)(4).

Event Description

Additional information received reported the implantable neurostimulator (ins) was nearing end of service and it was replaced.The patient had increased parkinson¿s disease symptoms, and they questioned the ins function.Impedances were measured in various positions and they were within normal limits.For open circuit failure ¿mri admitted within normal limit.¿ it was unknown if the patient had a 50% or greater symptom reduction and reprogramming was needed.The cause of the event was not determine and it was unknown if it was device related.The healthcare professional stated the cause was likely related to worsening parkinson¿s disease and neuropathy.At the time of this report the patient outcome was not recovered and the symptoms/issue were on going.

Manufacturer Narrative

(b)(4).

• 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: 3950089
• MDR Text Key: 4639954
• Report Number: 3004209178-2014-13349
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2014
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2014
• Date Device Manufactured: 11/08/2012
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00067 YR