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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN DEEP BRAIN STIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC NEUROMODULATION UNKNOWN DEEP BRAIN STIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number NEU_INS_STIMULATOR
Event Date 08/07/2012
Event Type  Malfunction  
Event Description

Literature: samura, k. , miyagi, y. , okamoto, t. , hayami, t. , kishimoto, j. , katano, m. , kamikaseda, k. Short circuit in deep brain stimulation. J. Neurosurg. 2012;117(5):955-961. Doi: 10. 3171/2012. 8. Jns112073. Summary: the authors undertook this study to investigate the incidence, cause, and clinical influence of short circuits in patients treated with deep brain stimulation (dbs). After the incidental identification of a short circuit during routine follow-up, the authors initiated a policy at their institution of routinely evaluating both therapeutic impedance and system impendence at every outpatient dbs follow-up visit, irrespective of the presence of symptoms suggesting possible system malfunction. This study represents a report of their findings after 1 year of this policy. Implanted dbs leads exhibiting short circuits were identified in 7 patients (8. 9% of the patients seen for outpatient follow-up examinations during the 12-month study period). The mean duration from dbs lead implantation to the discovery of the short circuit was 64. 7 months. The symptoms revealing short circuits included the wearing off of therapeutic effect, apraxia of eyelid opening, or dysarthria in 6 patients with parkinson disease (pd), and dystonia deterioration in 1 patient with generalized dystonia. All dbs leads with short circuits had been anchored to the cranium using titanium miniplate s. Altering electrode settings resulted in clinical improvement in the 2 pd cases in which patients had specific symptoms of short circuits (2. 5%) but not in the other 4 cases. The patient with dystonia underwent repositioning and replacement of a lead because the previous lead was located too anteriorly, but did not experience symptom improvement. In contrast to the sudden loss of clinical efficacy of dbs caused by an open circuit, short circuits may arise due to a gradual decrease in impedance, causing the insidious development of neurological symptoms via limited or extended potential fields as well as shortened battery longevity. The incidence of short circuits in dbs may be higher than previously thought, especially in cases in which dbs leads are anchored with miniplates. The circuit impedance of dbs should be routinely checked, even after a long history of dbs therapy, especially in cases of miniplate anchoring. Reported event: case 2. The patient had bilateral stimulation of the subthalamic nucleus (stn). The left lead had a short circuit with electrodes 0-3. Impedance measurements were less than 50 ohms. During the 5 years before the short circuit was identified, the patient experienced wearing off of therapeutic effect and freezing and propulsive gait during the off phase of medication, causing him to visit the hospital. Gait freezing may have resulted from a limited potential field due to the 2 anodes being involved in the short circuit. The patient also exhibited marked dysarthria and drooling. The patient's left implant delivered bipolar stimulation using contact 1 as a cathode and contact 3 as an anode. Therapy impedance was 794 ohms. Examination of system impedance revealed a short between contacts 3 and 0. Contact 0 was 6. 5mm under the midcommissural plane, suggesting a location in the ventral area of the stn. Altering the electrode setting to a unipolar stimulation using contacts 1 and 2 as cathodes led to the subjective alleviation of freezing and propulsion, but the sense of wearing off was not subjectively altered. These findings suggested that a short circuit between contacts 3 and 0 unexpectedly had limited the spread of the therapeutic potential field around contact 1. Short circuits were not suggested in radiographic examinations and were associated with no open circuits in a unipolar configuration. The cause of the short circuit was not identified.

 
Manufacturer Narrative

Product id: neu_unknown_lead, serial#: unknown, product type: lead; product id: neu_unknown_lead, serial#: unknown, product type: lead. The actual event dates were not provided. This date is based on the date of publication of the article. Patients were implanted with implantable neurostimulator: model 7424 or 7426 and lead model: 3387 or 3389. It was unknown which models this particular patient was implanted with. (b)(4).

 
Manufacturer Narrative

(b)(4).

 
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Brand NameUNKNOWN DEEP BRAIN STIMULATOR
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 120
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 Key2860888
Report Number3007566237-2012-02921
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Literature,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/09/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/06/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberNEU_INS_STIMULATOR
Device Catalogue NumberNEU_INS_STIMULATOR
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/29/2013
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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