MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION KINETRA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 7428

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problems Stroke/CVA (1770); Unspecified Infection (1930); Paresis (1998); Seizures (2063); Depression (2361)

Event Type  Injury  

Event Description

Volkmann, j., mueller, j., deuschl, g., kühn, a.A., krauss, j.K., poewe, w., timmermann, l., falk, d., kupsch, a., kivi, a., schneider, g-h., schnitzler, a., sudmeyer, m., voges, j., wolters, a., wittstock, m., müller, j-u., hering, s., eisner, w., vesper, j., prokop, t., pinsker, m., schrader, c., kloss, m., kiening, k., boetzel, k., mehrkens, j., skogseid, i.M., ramm-pettersen, j., kemmler, g., bhatia, k.P., vitek, j.L., benecke, r.Pallidal neurostimulation in patients with medication-refractory cervical dystonia: a randomised, sham-controlled trial.The lancet.Neurology.1474;2014 aug 7.Doi: 10.1016/s1474-4422(14)70143-7.Summary: cervical dystonia is managed mainly by repeated botulinum toxin injections.We aimed to establish whether pallidal neurostimulation could improve symptoms in patients not adequately responding to chemodenervation or oral drug treatment.In this randomised, sham-controlled trial, we recruited patients with cervical dystonia from centres in germany, norway, and austria.Eligible patients (ie, those aged 18¿75 years, disease duration =3 years, toronto western spasmodic torticollis rating scale [twstrs] severity score =15 points) were randomly assigned (1:1) to receive active neurostimulation (frequency 180 hz; pulse width 120 s; amplitude 0¿5 v below adverse event threshold) or sham stimulation (amplitude 0 v) by computer-generated randomisation lists with randomly permuted block lengths stratified by centre.All patients, masked to treatment assignment, were implanted with a deep brain stimulation device and received their assigned treatment for 3 months.Neurostimulation was activated in the sham group at 3 months and outcomes were reassessed in all patients after 6 months of active treatment.Treating physicians were not masked.The primary endpoint was the change in the twstrs severity score from baseline to 3 months, assessed by two masked dystonia experts using standardised videos, analysed by intention to treat.This trial is registered with clinicaltrials.Gov, number nct00148889.Between jan 19, 2006, and may 2 9, 2008, we recruited 62 patients, of whom 32 were randomly assigned to neurostimulation and 30 to sham stimulation.Outcome data were recorded in 60 (97%) patients at 3 months and 56 (90%) patients at 6 months.At 3 months, the reduction in dystonia severity was significantly greater with neurostimulation (¿5¿1 points [sd 5¿1] , 95% ci ¿7¿0 to ¿3¿5) than with sham stimulation (¿1¿3 [2¿4], ¿2¿2 to ¿0¿4, p=0¿0024; mean between-group difference 3¿8 points, 1¿8 to 5¿8) in the intention-to-treat population.Over the course of the study, 21 adverse events (fi ve serious) were reported in 11 (34%) of 32 patients in the neurostimulation group compared with 20 (11 serious) in nine (30%) of 30 patients in the sham-stimulation group.Serious adverse events were typically related to the implant procedure or the implanted device, and 11 of 16 resolved without sequelae.Dysarthria (in four patients assigned to neurostimulation vs three patients assigned to sham stimulation), involuntary movements (ie, dyskinesia or worsening of dystonia; fi ve vs one), and depression (one vs two) were the most common non-serious adverse events reported during the course of the study.Pallidal neurostimulation for 3 months is more effective than sham stimulation at reducing symptoms of cervical dystonia.Extended follow-up is needed to ascertain the magnitude and stability of chronic neurostimulation effects before this treatment can be recommended as routine for patients who are not responding to conventional medical therapy.Reported events: 1.1 patient had a failed implantation during which electrodes were misplaced.It was noted that the system was explanted.2.1 patient with neurostimulator had a device infection which was resolved within in the study period.It was noted that this was a serious adverse event which was related to the surgery or device and that was life-threatening, required hospital admission, or lengthened hospital stay.3.1 patient with neurostimulator had an electrode misplacement.It was noted that this was a serious adverse event which was related to the surgery or device and that was life-threatening, required hospital admission, or lengthened hospital stay.4.1 patient with neurostimulator had an implantable pulse generator (ipg) dislocation which was resolved within in the study period.It was noted that this was a serious adverse event which was related to the surgery or device and that was life-threatening, required hospital admission, or lengthened hospital stay.5.1 patient with neurostimulator had a hemiparesis or stroke which resolved within in the study period.It was noted that this was a serious adverse event which was related to the surgery or device and that was life-threatening, required hospital admission, or lengthened hospital stay.6.1 patient with neurostimulator had depression.It was noted that this was a serious adverse event which was related to medication or stimulation and that was life-threatening, required hospital admission, or lengthened hospital stay.The patient required psychiatric treatment.7.1 patient with sham stimulation had a device infection which was resolved within in the study period.It was noted that this was a serious adverse event which was related to the surgery or device and that was life-threatening, required hospital admission, or lengthened hospital stay.8.2 patients with sham stimulation had a surgical exchange of device components which was resolved within in the study period.It was noted that this was a serious adverse event which was related to the surgery or device and that was life-threatening, required hospital admission, or lengthened hospital stay.9.1 patient with sham stimulation had a tethering of extension cable which was resolved within in the study period.It was noted that this was a serious adverse event which was related to the surgery or device and that was life-threatening, required hospital admission, or lengthened hospital stay.10.1 patient with sham stimulation had an electrode dislocation which was resolved within in the study period.It was noted that this was a serious adverse event which was related to the surgery or device and that was life-threatening, required hospital admission, or lengthened hospital stay.11.1 patient with sham stimulation had an electrode dislocation.It was noted that this was a serious adverse event which was related to the surgery or device and that was life-threatening, required hospital admission, or lengthened hospital stay.12.1 patient with sham stimulation had a seizure which was resolved within in the study period.It was noted that this was a serious adverse event which was related to the surgery or device and that was life-threatening, required hospital admission, or lengthened hospital stay.13.1 patient with sham stimulation had an implantable pulse generator (ipg) infection which was resolved within in the study period.It was noted that this was an adverse event which was related to the surgery or device.The source literature included the following device specifics: kinetra (model # 7428) and dbs lead (model # 3387 or 3389).Further information has been requested; a supplemental report will be submitted if additional information is received.

Manufacturer Narrative

Age at time of event: this value is the average age of the patients reported in the article as specific patients could not be identified.Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.Concomitant medical products: product id neu_unknown_lead, lot# unknown, product type: lead; product id neu_unknown_lead, lot# unknown, product type: lead; product id 7428, lot# unknown, product type: implantable neurostimulator; product id 7428, lot# unknown, product type: implantable neurostimulator; product id neu_unknown_lead, lot# unknown, product type: lead; product id neu_unknown_ext, lot# unknown, product type: extension; product id neu_unknown_ext, lot# unknown, product type: extension; product id neu_unknown_lead, lot# unknown, product type: lead; product id neu_unknown_lead, lot# unknown, product type: lead; product id 7428, lot# unknown, product type: implantable neurostimulator; product id neu_unknown_ext, lot# unknown, product type: extension; product id 7428, lot# unknown, product type: implantable neurostimulator; product id 7428, lot# unknown, product type: implantable neurostimulator; product id neu_unknown_lead, lot# unknown, product type: lead; product id neu_unknown_ext, lot# unknown, product type: extension.(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: KINETRA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• 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 Key: 4133560
• MDR Text Key: 18367935
• Report Number: 3007566237-2014-02806
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2014

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 Model Number: 7428
• Device Catalogue Number: 7428
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2015
• Initial Date FDA Received: 10/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/05/2015
• 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): Other; Required Intervention
• Patient Age: 00056 YR