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

Model Number NEU_INS_STIMULATOR

Device Problems Break (1069); Migration or Expulsion of Device (1395); Low Battery (2584); Malposition of Device (2616)

Patient Problems Neurological Deficit/Dysfunction (1982); Renal Failure (2041); Seroma (2069); Skin Erosion (2075); Therapeutic Effects, Unexpected (2099); Respiratory Failure (2484); Ambulation Difficulties (2544); Tissue Breakdown (2681)

Event Type  Injury  

Event Description

Sobstyl, m., kmiec, t., zabek, m., szczaluba, k., mossakowski, z.Long-term outcomes of bilateral pallidal stimulation for primary generalised dystonia.Clinical neurology and neurosurgery.2014;126c:82-87.Doi: 10.1016/j.Clineuro.2014.08.027 summary: bilateral pallidal stimulation is an established surgical management for patients with primary generalised dystonia (pgd).The aim of this study was to present our long-term experience of bilateral pallidal stimulation in patients with pgd.The study population is composed of 12 patients diagnosed with of pgd (six patients with dyt-1 positive pgd and six patients with dyt-1 negative pgd).The patients were operated under general anaesthesia with no intraoperative target refinement by means of microrecording.The stereotactic technique was based on a combination of the indirect targeting technique relative to the midcommisural point coordinates and direct image-guided mri target refinement.The formal objective assessment included the burke-fahn-marsden dystonia rating scale (bfmdrs).The bfmdrs assessment was performed before and after it annually up to five years when bilateral pallidal stimulation was switch ed on and compared to baseline scores.Baseline bfmdrs scores and subsequent follow-up bfmdrs scores were compared with the use of a wilcoxon signed-rank test for matched pairs.A two-tailed probability level of 5% (p <(><<)> 0.05) was considered significant.At the last follow-up visit, in patients with dyt-1 positive pgd the mean preoperative functional and motor scores of the bfmdrs decreased from 14.0 and 63.75 to postoperative scores of 5.75 (p = 0.068) and 22.0 (p = 0.066), respectively.In patients with dyt-1 negative pgd the mean preoperative functional and motor scores of the bfmdrs decreased from 13.0 and 46.5 to postoperative scores of 5.25 (p = 0.066) and 22.75 (p = 0.068), respectively.The hardware-related complications affected seven patients.Our results indicate that bilateral pallidal stimulation is an effective treatment for patients with dyt-1 positive and dyt-1 negative pgd.The most common hardware-related complication (dbs lead breakage) in our series was associated with the slippage of the connector to the cervical area.To prevent this complication after changing the surgical technique (suturing and placing the connector in parietal region) we did not observe these complications.Unilateral ipg failure resulted in the development of severe status dystonics.Reported events: 1.One patient experienced rapid depletion of one implantable neurostimulator (ins) causing severe life-threatening status dystonics.The patient experienced severe rhabdomyolysis with acute renal and respiratory failure, and required sedation with tracheal intubation.The patient was dialysed for 5 weeks, sedated and mechanically ventilated.The depleted ins was exchanged on the day following emergency hospital admission.After reassuming bilateral dbs, the patient¿s condition improved, but due to severe rhabdomyolysis, the patient became wheelchair bound.At the time of this report, the patient remained under extensive rehabilitation program.One patient experienced rapid depletion the implantable neurostimulator (ins) causing rapid aggravation of dystonia eight months after implant.The patient underwent a surgical revision and implantation of a new ins with a good outcome.The patient¿s neurological status returned to the preoperative level of clinical improvement obtained under the bilateral pallidal stimulation following the replacement.One patient had development of sterile seromas bilaterally at the ins sites 51 months after implant.The patient underwent surgical revision under local anesthesia with a good outcome.One patient had erosion over the connector site in the left postauricular area 36 months after implant.The patient underwent wound debridement and replacement of the connector to parietooccipital region with a good outcome.One patient had erosion over the connector site in the right postauricular area 43 months after implant.The patient underwent wound debridement and replacement of the connector to parietooccipital region with a good outcome.One patient had breakage of the left deep brain stimulation (dbs) lead near the connector site 8 months after implant.The patient underwent stereotactic reimplantation of a new lead with a good outcome and without neurological sequelae.It was noted that the lead breakage was associated with the slippage of the connector to the cervical area.One patient had breakage of the left dbs lead near the connector site 36 months after implant.The patient underwent stereotactic reimplantation of a new lead with a good outcome and without neurological sequelae.It was noted that the lead breakage was associated with the slippage of the connector to the cervical area.One patient had breakage of the left dbs lead near the burr hole cup 13 months after implant.The patient stereotactic reimplantation of the new lead with a good outcome and without neurological sequelae.It was noted that the lead breakage was associated with the slippage of the connector to the cervical area.One patient had breakage of the right dbs lead near the burr hole cup 22 months after implant.The patient underwent stereotactic reimplantation of a new lead with a good outcome and without neurological sequelae.It was noted that the lead breakage was associated with the slippage of the connector to the cervical area.One patient experienced unsatisfactory control of dystonic movement 16 months after implant.The patient showed initial good improvement to stimulation, but reported suboptimal improvement on one side of the body despite numerous changes of stimulation parameters.There porter stated that the unsatisfactory control of dystonic movements was related to suboptimal electrode placement.The patient underwent replacement of the dbs lead to a new position; the lead was relocated 2mm posterior and 2 mm lateral to its previous position with a good clinical response.The source literature included the following device specifics: lead model 3387 and implantable neurostimulators itrel ii, soletra or activa were used.Further information has been requested; a supplemental report will be submitted if additional information is received.

Manufacturer Narrative

This value is the average age of the patients reported in the article as specific patients could not be identified.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_ins_stimulator, lot# unknown, product type: implantable neurostimulator.Product id: 3387, lot# unknown, product type: lead.(b)(4).

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• 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: 4170823
• MDR Text Key: 21972199
• Report Number: 3007566237-2014-02976
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: Physician
• Type of Report: Initial
• Report Date: 09/18/2014

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: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2014
• Initial Date FDA Received: 10/14/2014
• 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; Life Threatening; Required Intervention; Disability
• Patient Age: 00022 YR