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); Malposition of Device (2616); Device Operates Differently Than Expected (2913)

Patient Problems Dysphagia/ Odynophagia (1815); Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Paresis (1998); Cognitive Changes (2551)

Event Type  Injury  

Event Description

Contarino, m.F., van den munckhof, p., tijssen, m.A.J., de bie, r.M.A., bosch, d.A., schuurman, p.R., speelman, j.D.Selective peripheral denervation: comparison with pallidal stimulation and literature review.Journal of neurology.2014;261(2):300-308.Doi: 10.1007/s00415-013-7188-4 summary: patients with cervical dystonia who are nonresponders to botulinum toxin qualify for surgery.Selective peripheral denervation (bertrand¿s procedure, spd) and deep brain stimulation of the globus pallidus (gpi-dbs) are available surgical options.Although peripheral denervation has potential advantages over dbs, the latter is nowadays more commonlyperformed.We describe the long-term outcome of selective peripheral denervation as compared with gpi-dbs, along with the findings of literature review.Twenty patients with selective peripheral denervation and 15 with gpi-dbs were included.Tsui scale, a visual analogue scale, and the global outcome score of the toronto western spasmodic torticollis rating scale were used to define a ¿¿combined global surgical outcome¿¿.The ¿¿combined global surgical outcome¿¿ for patients with selective peripheral denervation or pallidal stimulation was respectively ¿¿bad¿¿ for 65 and 13.3 %, ¿¿fair-to-good¿¿ for 30 and 26.7 %, and ¿¿marked¿¿ improvement for 5 and 60 % (p\0.001).Improvement on visual analogue scale (p\0.002), global outcome score (p\0.002), and tsui score (p\0.000) was larger for the pallidal stimulation group.Seventy-five percent of patients with selective peripheral denervation and 60 % of patients with pallidal stimulation reported side effects.Seven patients with selective peripheral denervation successively underwent gpi-dbs, with a further significant improvement in the tsui score (-48.6 ± 17.4 %).Gpi-dbs is to be preferred to selective perip heral denervation for the treatment of cervical dystonia because it produces larger benefit, even if it can have more potentially severe complications.Gpi-dbs is also a valid alternative in case of failure of spd.Reported events: 1 patient experienced intraoperative hemorrhage with hemiparesis, slight cognitive decline, slight dysphagia, and urinary incontinence.It was noted that this patient categorized as having a ¿bad¿ outcome due to the serious adverse event; 1 patient experienced an electrode fixation replacement.It was noted that the patient required additional surgery to reposition the electrodes as a result.It was noted that the patient then had good effect.This patient was categorized as having a ¿bad¿ outcome as an additional surgery had been required; 1 patient experienced a lead fracture and contralateral lead migration.It was noted that the patient required additional surgery as a result; 1 patient experienced a painful moving implantable neurostimulator (ins).It was noted that the patient required additional surgery as a result; 1 patient experienced a tight extension.It was noted that the patient required additional surgery as a result.The source literature included the following device specifics: lead model 3389 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: product id 3389, lot# unknown, product type lead, product id 3389, 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: 3869671
• MDR Text Key: 4456663
• Report Number: 3007566237-2014-01622
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 05/22/2014

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: 05/22/2014
• Initial Date FDA Received: 06/12/2014
• 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): Required Intervention
• Patient Age: 00056 YR