MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problems Intermittent Continuity (1121); Energy Output To Patient Tissue Incorrect (1209); Device Operates Differently Than Expected (2913)

Patient Problems Device Overstimulation of Tissue (1991); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Date 04/14/2016

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 37642, serial# (b)(4), product type: programmer, patient.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The consumer reported via a manufacturer representative (rep) that the patient's symptoms did not improve after the last battery change and he had been struggling ever since.The clinician had reprogrammed him multiple times without any improvement.His symptoms had not been controlled and had not done well ever since the last routine battery change.The consumer also reported that the patient programmer was acting up; the screen was flickering and turning the implantable neurostimulator (ins) on by itself after she turned it off.The ins increased stimulation and turned on by itself while using the programmer.The patient seemed to get overstimulated when turning the device off or switching groups.The patient was seen in the clinic on (b)(6) 2016 and the programmer seemed to be working ok.They were able to change groups without a problem.The patient's symptoms did seem to be worse when he came in, so they changed him to his d settings and made a slight decrease in voltage and he felt much better.The consumer was still concerned about the programmer because she had problems getting the screen to turn on and access his implant, even though it was a new one.The rep later reported that the cause was not determined.The consumer said the ins issue happened again on (b)(6) 2016.They turned the ins off and it turned on by itself.They were going to try and record it happening if possible.The rep further reported that the patient programmer was unable to power on about two weeks prior to (b)(6) 2016.It had been acting strange and he tried three or four different brands of batteries.He finally tried a (b)(6) alkaline brand battery and it turned on.The rep verified that they had tried all alkaline batteries.The rep tried with (b)(6) batteries and everything seemed to be working fine, but the patient did not seem confident and wanted a replacement.The programmer had not been dropped or gotten wet.This was not an out of box failure.The rep later reported the programmer had a blank screen.They got it working with different batteries, but the patient was still not confident it would stay working and wanted a replacement.The patient's indication(s) for use were parkinson's dual and movement disorders.

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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5993193
• MDR Text Key: 56165017
• Report Number: 3004209178-2016-20205
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2017
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2016
• Date Device Manufactured: 02/08/2016
• 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: 68 YR