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U.S. Department of Health and Human Services

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

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37601
Event Type  Injury  
Event Description

The health care professional (hcp) reported via a manufacturer representative (rep) that there was troubleshooting needed for an imp edance issue. The patient related to the event had severe intractable bilateral essential tremor of the upper extremities, head, trunk, and voice tremor. The indication for use was essential tremor. The patient had a bilateral ventrointermediate nucleus deep brain stimulation (dbs) implanted in (b)(6) 2014. The consumer reported improvement of her symptoms since the dbs had been instituted, however, she did recall that ever since the very first programming session she was noted to have a high sensitivity and low side effect threshold. Over the last month, the patient had worsening head tremor and also had an electrical shock painful sensation when she tapped her scalp over the parietal connectors on the left side. This seemed to indicate a break in the insulation that was experienced when the lead was stressed. They would probably need to replace this lead to resolve the issue. X-rays were done to see if there was a disconnection or obvious circuitry probable over the left connector. Even if the x-rays were normal, they may benefit to revising the connection leads to insulate them better to see if this can avoid the electrical phenomenon. This would not be like ly to effect her tremor control or side effect stimulation thresholds. There was a skull x-ray showing the area that the surgeon was concerned about. It was on the left side, which matched where the patient felt the shocks, but it was a more frontal location than the surgeon was expecting. Coiling could be seen very faintly if zoomed in on the lead pictures. When they ran impedances initially on the left at the default 0. 7 volts, they had out of range impedances. Then they re-ran the impedances at 1. 5 volts and the impedances were in range. This made the hcp think that there was either an intermittent issue or the impedances were greater than 10000 ohms. Impedance testing did not reveal any major abnormalities. There were two contacts with a high impedance on the left that returned to normal impedance when tested at a 1. 5 volt testing threshold, which would indicate a normal impedance profile. The patient's scalp incision sites were clean, dry, and intact. She appeared to have a duel extension lead tunnel to the left. There was an implantable pulse generator (ipg) in the left intraclavicular position with a small amount of swelling with no erythema or tenderness. However, she had tenderness and a pulse-like shock sensation when tapped over the connector sites. This sensation disappeared when the device was turned off and it was present when the right or the left side was activated. The right side case was positive, 9 negative, pulse width 60, frequency of 150, amplitude of 1. 7 volts. The left side case was positive, 3 negative, pulse width 60, frequency of 150, amplitude of 1. 7 volts. There was some testing of the 0, 1, and 2 contacts on the left side, all of which produced unacceptable paresthesia and/or motor drive thresholds. It was experimented with a pulse width increased to 90 but were only able to achieve 1. 5 volts at this pulse width without developing unacceptable motor drive side effects. This side was returned to pulse width of 60, amplitude to 1. 7 volts, and monopolar stimulation to the number 9 electrode. There were two problems being experienced by the patient. She had very low side effect thresholds with stimulation. This was not a new phenomenon and was present since the initial program ing. It was possible that she was developing some tolerance and tremor breakthrough, and since higher voltages are being required she was unable to tolerate these due to the low thresholds. This was most likely due to initial lead placement and cannot be easily co rrected. The second problems was a shock-like painful sensation. After follow-up with the rep, the patient had worsening of tremor and would have a revision. The date of the revision was not yet scheduled. No outcome or intervention was reported regarding this event. If additional information is received, a follow-up report will be sent.

 
Manufacturer Narrative

Product id 3708660, serial# (b)(4), implanted: 2014 (b)(6); product type extension product id 3708660, serial# (b)(4), implanted: 2014 (b)(6); product type extension product id 3387s-40, lot# va09evkv02, implanted: 2014 (b)(6); product type lead product id 3387s-40, lot# va09evkv02, implanted: 2014 (b)(6). Product type lead. (b)(4).

 
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Brand NameACTIVA
Type of DeviceSTIMULATOR, 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 Key4976727
Report Number3004209178-2015-15521
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/17/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/06/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/14/2015
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/17/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/14/2014
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: 08/06/2015 Patient Sequence Number: 1
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