MAUDE Adverse Event Report: IPG MFG SWITZERLAND SOLETRA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 7426

Device Problems Low impedance (2285); Malposition of Device (2616); Device Operates Differently Than Expected (2913); Impedance Problem (2950)

Patient Problems Muscular Rigidity (1968); Neurological Deficit/Dysfunction (1982); Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Effects, Unexpected (2099); Tingling (2171); Complaint, Ill-Defined (2331); Neck Pain (2433)

Event Type  Injury  

Event Description

It was reported that 18 months prior to report, the impedance values of the patient¿s #0 and #2 electrodes suddenly decreased.It was further reported that this ¿resulted in high-power stimulation and the patient presented with symptoms of internal capsule stimulation.¿ it was stated the patient¿s physician considered the ¿possibility of a lead problem¿ and it was decided to replace the patient¿s leads on (b)(6) 2014.It was reported that following the replacement of the lead, the patient¿s ¿impedance values had not changed at all.¿ it was stated ¿the problem was not attributable to the lead¿ and ¿the physician did not know what might be a possible cause.¿ additional information stated that when stimulation was performed on (b)(6) 2013 there ¿were fluctuations in the electric current value due to fluctuations in impedance.¿ it was reported that when impedances were checked on (b)(6) 2013 ¿there were no problems with the left electrode¿ and that the right electrode¿s #0 and #2 had ¿low¿ impedances.Impedance records indicate the ¿low¿ values for contacts #0 and #2 were 346 ohms and 479 ohms respectively.It was stated the patient¿s ¿neck was still in pain¿ and that it was ¿difficult to face right.¿ it was reported that ¿tension in the right dominant sternocleidomastoid (scm) was the most noticeable¿ and that it was also noticeable in the patient¿s right trapezius muscle.It was noted the patient had ¿botulinus administered on (b)(6) 2013 and that ¿it was difficult to control the patient¿s symptoms in their neck region, so botulinus was used concurrently.¿ it was reported that ¿dystonia was not triggered through stimulation in the left finger like it was in the past.¿ it was stated the patient had been previously hospitalized at a neurological hospital in (b)(6) 2012.It was further reported that impedance testing performed on (b)(6) 2014 found ¿low¿ impedances on electrodes #0 and #2 of 259 ohms and 356 ohms respectively ¿ both measured at 2.5 volts.It was again noted these impedances were ¿too low.¿ while performing stimulation testing it was reported the patient experienced their left hand being ¿heavy.¿ it was stated the patient could not fully extend their fourth or fifth fingers at times during the test.Eventually it was noted the patient could extend their fourth finger ¿if done consciously.¿ it was additionally reported that a surgery was performed on (b)(6) 2014 ¿to shift the dbs (deep brain stimulation) electrode on both sides.¿ it was stated this was performed because ¿there was a problem with the electrode placement position itself¿ and ¿there was a concern about whether the impedance was low due to the dbs electrode.¿ it was further stated there ¿seemed like there was a problem with the dbs electrode itself (disconnection?).¿ it was reported that after the surgery to shift the electrodes, the impedances in the right electrodes #0 and #2 were ¿still low.¿ the ¿low¿ therapeutic impedance values when measured at 3 volts were found to be 269 ohms and 374 ohms for electrodes #0 and #2 respectively.It was stated that ¿when the electric current was applied¿ the patient complained of ¿tingling sensations in the implantable neurostimulator (ins) region.¿ it was further stated the patient reported the ¿ins was painful¿ and the ¿ins was tingling.¿ it was reported it was ¿slightly difficult to extend [their] left fingers¿ and ¿slightly difficulty to bend [their] right fingers¿ during a stimulation test.It was additionally reported that during the stimulation test the patient¿s right upper limb and lower left limb were ¿slightly heavy¿ and the right bottom half of the patient¿s body ¿felt tingly and fuzzy.¿ it was stated the patient¿s shoulder also felt ¿strained.¿ impedance testing performed on (b)(6) 2014 indicated the right electrodes #0 and #2 had impedances of 294 ohms and 432 ohms respectively.Impedance testing also indicated the right bipolar electrode pair 1-3 had an impedance value ¿>2000¿ ohms.It was noted that electrodes #0 and #2 ¿were both five years old.¿ additional information reported ¿electrode replacement surgery was performed, however, the resistance value was low and did not change.¿ it was stated there was ¿possibly a problem with the electrode and there was a problem with the indwelling position of the lead as well.¿ it was noted that on (b)(6) 2014 a lead was ¿extracted¿ and would be collected at a later date for analysis.It was additionally noted that ¿since the low resistance continues even after changing the ins and lead, the cause of the low resistance could be from the extension part.¿ it was noted the patient was admitted to the hospital for ¿recovery¿ following their lead replacement procedure.Additional information stated ¿stinging sensations persisted¿ after the lead replacement was completed.Additional information stated the patient ¿had not had effective therapy¿ and the ¿cause was not determined¿ as of 17 days after initial report.A supplemental report will be filed if additional information is received.

Manufacturer Narrative

Concomitant medical products: product id 3387-28, serial# (b)(4), implanted: (b)(6) 2007, explanted: (b)(6) 2014, product type: lead.(b)(4).

• Brand Name: SOLETRA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• 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 Key: 3855294
• MDR Text Key: 4655872
• Report Number: 9614453-2014-01067
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2013
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2014
• Initial Date FDA Received: 06/09/2014
• Date Device Manufactured: 11/24/2011
• 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 Outcome(s): Hospitalization; Required Intervention