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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37603
Device Problems Break; Failure to Interrogate ; Inappropriate Shock; Device Displays Incorrect Message ; Communication or Transmission Problem; Electromagnetic Compatibility Problem
Event Date 07/10/2015
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_ext, product type: extension. Product id: 3389, product type: lead. (b)(4).

 
Event Description

The patient reported that symptom returned. The patient was implanted for essential tremors on the right side. The patient had good reduction in symptoms right after first programming on (b)(6), then 24 hours later the patient started having problems. It was also noted that the programming has gone well and the patient received good benefit. The programmer reads the setting was being in service, however, tremor has returned and no relief of symptoms. The patient was driving and then his tremors returned. When the patient returned home, he turned the device off then turned device on, no changes. "they have changes setting not change in symptoms". It was confirmed that the patient has not fallen or accidentally hit his device, no trauma. The patient did contact his clinic. Two days later the patient was seen at his doctor's office and the ins was checked with the clinician programmer. The ins was working as planned. The patient came back for reprogramming. Less than a week later the patient's health care provider (hcp) reported a loss of therapy. It has happened twice now, where all of a sudden, the patient's tremor was no longer controlled by the ins. The patient went to his doctor for a final adjustment. The device was working for only 24 hours. The programmer indicated the ins was on and working. The patient has an insulin pump that he clips to his shirt collar on the opposite side of his chest from the implantable neurostimulator (ins). When the clip is close to the ins, the patient programmer (pp) will not read the ins nor will the pp work. The patient knows the device is on as he feels tingling in his right arm when the stimulation is on. The patient was not feeling any tingling in his hand when device comes on like he used to. When the insulin pump was clipped to the patient's belt, it does not affect the ins and the pp from communicating. The hcp was told that the ins was on but the patient verified that he has been playing with the settings via the pp. It was further stated that the tremor came back, even with the program running but the patient had shut the system off, as nothing they did seemed to work. The hcp turned it on and the patient felt the program start once again. The patient drove all the way home and it happened again; program on and tremor back. The system was interrogated; no codes and no impedance issue. Emi compatibility guidelines were requested. The following is the patient's diary information for (b)(6) 2015: 5:40 pm - on at 2. 00 then up to 2. 80 -nothing then up to 3. 40 - big buzz up arm then down to 2. 8 - cue test worked 5:45 - down to 2. 00 -seems to work but not with cue then up to 2. 60 - buzz - 90% with cue then up to 2. 80 - buzz - 90% with cue 5:50 - down to 2. 00 - turned off and out of regulation error message 00r with phone to doctor shown on page 106 appeared 7:05 - turned on at 2. 00 - buzz then up to 2. 80 - felt no difference - no help with cue then down to 2. 00 - seemed to be working then up to 3. 40 - buzz then down to 2. 80 - no help with cue then down to 2. 00 - not sure its working 8:30 - using my left hand, i pulled my head toward my left shoulder and felt a buzz in my right hand 9:55 -changed from 2. 00 to 2. 80 - felt a buzz and worked with cue back to 2. 00 from 2. 80 - hand writing feels better turned off note: between 8:30 and 9:55 i sometimes got a buzz when yawning. Cue was referring to the patient's pool cue when he checks to see if he can play "snooker. " the next day the hcp reported again a change in the patient's therapy. The change was considered sudden but also reported as gradual. The patient continues to have intermittent therapy/tremor, tremor comes and goes; and intermittent return of symptoms and tingling in right hand. The hcp has tried different scenarios and was not able to replicate the problem the patient had. The device was off when the patient arrived at the clinic. The hcp turned the device on with the remote and the ins was interrogated, no codes were present. The patient felt a sensation in his right arm, and noticed a reduction of tremor. The patient's wife is confident with the navigation of the pp. The hcp asked the patient's wife to leave the pp on over the next several weeks, and just push the orange button when they need to check the status of the program, or to turn the device off at night; they can push the off switch. Impedances were tested at 1. 5v and c-0 were >10k; when turning head to the right contacts 1-2 were 195ohms and when turning to left no problem. Telemetry strips showed c<(>&<)>0 were >20,000 ohms and 1<(>&<)>2 were 196 ohms. Change in therapy was related to positional movement. The patient sometimes feels tingling in his right hand. The hcp will try palpating the ins and extension connection to determine location of the problem. After doing some further diagnostic testing with the patient, putting strain on the lead/extension connection, a short circuit with 1 <(>&<)>2 and open with c<(>&<)>0. The implanting hcp will be taking the patient to the or and open up the lead/extension site to see if fluid got in the connection. The hcp will most likely replace the extension. Further information was requested but the hcp returns to the office on 08/05/2015. If additional information is received, a follow up report will be sent.

 
Manufacturer Narrative

Concomitant medical products: product id 3708640, serial# (b)(4), implanted: (b)(6) 2015. Product id 3708640, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id 3389-40, lot# 0209282986, product type: lead.

 
Event Description

The patient (hcp) reported via the company representative (rep) in the middle of (b)(6) that the ins was still not answering to programmer settings. The patient visited the clinic and the doctor tested the system. System testing showed 3 out of 4 contacts were faulty. The doctor has scheduled the patient for extension replacement. It was noted that the programmer was faulty.

 
Manufacturer Narrative

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

 
Event Description

Additional information received from a health care provider (hcp) via a manufacturer representative reported the patient experienced a buzzing and zapping sensation and a loss of therapy.

 
Manufacturer Narrative

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

 
Event Description

Additional information received from the consumer reported that the extensions had broke. The patient had undergone a revision to replace the extensions on (b)(6)2015 and the issue resolved at that time.

 
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Brand NameACTIVA
Type of DeviceSTIMULATOR, 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 NEUROMODULATION
7000 central avenue ne rcw215
minneapolis MN 55432
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis , MN 55432
7635263920
MDR Report Key4988000
Report Number3004209178-2015-15662
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/05/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/10/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/28/2016
Device MODEL Number37603
Device Catalogue Number37603
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/29/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/10/2015 Patient Sequence Number: 1
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