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Model Number 7428
Event Date 03/01/2008
Event Type  Injury  
Manufacturer Narrative

It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Concomitant products: product id 3389, lot # unknown, product type lead; product id 3389, lot # unknown, product type lead. (b)(4).

Event Description

Amtage, f. , lambeck, j. , rutsch, s. , prokop, t. , pinsker, m. , rijntjes, m. Behind the screen: pseudobulbar symptoms after deep brain stimulation. In: nikkhah g, pinsker m, eds. Stereotactic and functional neurosurgery. Vol 117: springer vienna; 2013:43-46. Summary: thalamotomy was formerly used to treat different tremor syndromes. Nowadays deep brain stimulation has become an established technique to treat different movement disorders. The combination of these two stereotactic interventions is rare. We present a patient which a right-sided tremor syndrome with and underlying pathology of combined essential tremor and parkinsonian tremor was successfully treated initially with bilateral deep brain stimulation in the subthalamic nucleus resulted in hemidystonia pathological laughing and crying, dysarthria and dysphagia, all due to dislocation of the stimulation electrode contacting the internal capsule. After discontinuation of the high-frequency stimulation these side-effects disappeared, but were then reactivated by an lcd television in stand-by mode. In this report we discuss the pathophysiology of pseudobulbar symptoms and pathological laughing and crying in context of thalamotomy and dislocated dbs electrodes. Furthermore, we report on the occurrence that magnetic fields in the household have an impact on deep brain stimulation, even if they are in stand-by mode. Reported event: one (b)(6) female patient with a history of right-sided tremor syndrome which was treated by a left-sided thalamotomy had a deep brain stimulation (dbs) implantable neurostimulator (ins) implanted in the subthalamic nucleus (stn) for her emerging parkinson¿s disease (pd). Postoperatively, the patient complained of slight dysarthria and dystonia in the right leg when using stimulation. Several years later, the patient reportedly displayed right-sided hemidystonia and aggravation of the dysarthria, in combination with pseudobulbar signs such as dysphagia and pathological laughing and crying (plc) when the amplitude was increased. Seven years after implant, the patient admitted herself to the hospital and had a cranial ct scan taken. The ct scan revealed a dislocation of the left-sided electrode, leading to a stimulation of the medial parts of the internal capsule with the two uppermost contacts. The reporter stated that the right-sided electrode was placed in a pronounced dorsolateral position, stimulating the internal capsule at low amplitude at the second proximal contact. The reporter stated that testing of the remaining contacts for therapeutic effect reportedly showed no benefit to the pd symptoms. The ins was then switched off and the dysarthria, dysphagia, plc and right-sided hemidystonia disappeared completely; the patient was then discharged from the hospital. The patient denied a revision of the electrodes, as she was experiencing well-being under medication. The reporter stated that the patient¿s pseudobulbar symptoms were due to dislocation of both dbs stimulation leads into the internal capsule and the hemidystonic syndrome was provoked by the high-frequency stimulation of the cortico-spinal tract within the left internal capsule. The reporter suggested that there was a concomitant vulnerability of the circuit due to the left-sided thalamotomy. The reporter stated that the left-sided thalamotomy was not able to provoke plc by itself, only additional high-frequency stimulation of the internal capsule resulted in plc and other pseudobulbar symptoms. It was noted that the right-sided stimulation of the internal capsule did not produce a clinically-apparent dystonia, but rather spasticity of the left leg, since stimulation of only a small amplitude was applied. The reporter stated that switching off the right-sided stimulation yielded no benefit with respect to the plc, suggesting that bilateral pathology was therefore not mandatory to provoke plc. One month later, the patient reported a reappearance of the pseudobulbar symptoms during housework. The patient reportedly presented with right-sided hemidystonia and showed identical pseudobulbar symptoms as previously, including dysarthria, dysphagia and plc. The reporter stated that an assessment of the ins revealed that the high-frequency stimulation was again provoking the symptoms. The patient stated that stimulation had not been restarted by herself or a physician. The patient stated that the symptoms had suddenly reappeared while leaning over the television screen, which was in stand-by mode. The reporter stated that the magnetic field of the television interfered with the stimulator and switched it on again. It was noted that the magnetic switch of the stimulator had not been inactivated and the amplitude of the left-sided stimulation parameters had not been set to zero when stimulation had been turned off. It was noted that the amplitude of the right stimulation contact was still set to zero. The reporter stated that after deactivating the stimulator, the pseudobulbar signs promptly disappeared again. Further information has been requested; a supplemental report will be submitted if additional information is received.

Event Description

Additional information received reported that the patient's side effects of dysarthria, lack of benefit to pd symptoms, right leg dystonia, dysphagia, leg spasticity, and crying were due to lead dislocation. It was noted that clinical testing and a ct-scan had been performed. The reporter stated that an explant was not planned and there was no follow up available regarding the patient's status. The reporter stated that the approximate date of the patient's hemidystonia was (b)(6) 2008; the approximate date of the plc, dysarthria and dysphagia was (b)(6) 2008. The reporter stated that there were no possible device malfunctions observed.

Manufacturer Narrative

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Manufacturer (Section D)
route du molliau 31
tolochenaz MN 55421 120
CHINA 55421 1200
Manufacturer (Section G)
7000 central avenue ne rcw215
minneapolis MN 55432
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis , MN 55432
MDR Report Key3466513
Report Number3007566237-2013-03679
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 10/31/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date07/28/2009
Device MODEL Number7428
Device Catalogue Number7428
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/27/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/06/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 11/13/2013 Patient Sequence Number: 1