MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number NEU_INS_STIMULATOR

Device Problems Premature Discharge of Battery (1057); Migration or Expulsion of Device (1395); Malposition of Device (2616); Device Operates Differently Than Expected (2913)

Patient Problems Intracranial Hemorrhage (1891); Unspecified Infection (1930); Pulmonary Edema (2020); Seizures (2063)

Event Date 07/31/2013

Event Type  Injury  

Event Description

Hung, h.Y., tsai, s.T., lin, s.H., jiang, j.L., chen, s.Y.Uneven benefits of subthalamic nucleus deep brain stimulation in parkinson's disease-a 7-year cross-sectional study.Tzu chi medical journal.2013;25(4):239-245.Doi: 10.1016/j.Tcmj.2013.08.003.Summary: subthalamic nucleus deep brain stimulation (stn-dbs) for motor symptoms of parkinson¿s disease (pd) is promising.However, the benefits of stn-dbs are uneven for the cardinal motor symptoms, as well as for mentality and activities of daily living as the disease progresses.In this report, we will try to clarify which target symptoms have long-term effects during 7 years of stn-dbs.From february 2002 to february 2011, 120 pd patients who underwent stn-dbs were enrolled in this cross-sectional study.Data analysis was performed at postoperative follow-up periods of 1 year, 2 years, 5 years, and 7 years.The unified parkinson's disease rating scale (updrs) was evaluated in four combinations of levodopa/dbs, on/off.With levodopa off/dbs on, the updrs part iii score improved significantly within the 7 years of follow-up (p <(><<)> 0.001).Decrements in the degree of improvement in axial symptoms were observed after the 5th year.Despite significant improvement in the updrs part ii during the 7 years of follow-up, the score of the schwab and england activities of daily living scale declined after the 5th year of dbs.With levodopa off/dbs off, the scores for part iii and all subitems deteriorated in comparison with the preoperative levodopa off score after the 5th year of follow-up.Bradykinesia was significantly worse in the 5th and 7th years (p <(><<)> 0.05 and p <(><<)> 0.01, respectively) and the axial component was significantly worse in the 7th year (p <(><<)> 0.05).Stimulation side effects included hypophonia (20.8%), dysarthria (15%), sialorrhea (14.2%), and decreased memory (14.2%).Other surgically related adverse effects included intracranial hemorrhage (3.3%), pulmonary edema (n ¼ 3), deep vein thrombosis (n ¼ 1), seizure (n ¼ 1), depression (n ¼ 7), and mania/hypomania (n ¼ 11).Five electrodes were revised and two devices became infected.Dbs stimulation parameters remained stable except for a significant reduction in frequency in the 7th year.Long-term effects of dbs on motor disability are promising.Dbs showed uneven beneficial effects, and least improvement in axial symptoms and verbal fluency.The disease progressed despite significant positive effects of dbs on the cardinal motor disability symptoms of pd and quality of life at 7 years.Reported events: 1.1 patient with parkinson¿s disease experienced a symptomatic intracranial hemorrhage and only made a partial recovery.2.1 patient with parkinson¿s disease experienced a symptomatic intracranial hemorrhage and made a total recovery.3.2 patients with parkinson¿s disease experienced an asymptomatic intracranial hemorrhage.4.1 patient with parkinson¿s disease experienced seizures following stn dbs.The reporter stated that the patient recovered well.5.1 patient with parkinson¿s disease had an infection of the hardware.It was noted that the device required explant.6.1 patient with parkinson¿s disease had an infection of the hardware.It was noted that the device did not require explant.7.3 patients with parkinson¿s disease experienced pulmonary edema following stn dbs.The reporter stated that the patients recovered well.8.4 patients with parkinson¿s disease had a unilateral lead that was sub-optimally placed and needed to be repositioned.9.1 patient with parkinson¿s disease had bilateral leads that were sub-optimally placed and needed to be repositioned.10.6 patients with parkinson¿s disease had a wire revision.11.2 patients with parkinson¿s disease had battery failure.The reporter stated that the patients had standard stimulation parameters and experienced early termination of the implantable neurostimulator (ins) battery.12.1 patient with parkinson¿s disease experienced implantable neurostimulator (ins) migration.13.5 patients with parkinson¿s disease experienced lead problems.Further information has been requested; a supplemental report will be submitted if additional information is received.

Manufacturer Narrative

The actual event dates were not provided.This date is based on the date of publication of the article.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Concomitant medical products: product id: 3389, lot# unknown, product type: lead.Product id: 3389, lot# unknown, product type: lead.Product id: 3389, lot# unknown, product type: lead.Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator.Product id: 3389, lot# unknown, product type: lead.Product id: 3389, lot# unknown, product type: lead.Product id: 3389, lot# unknown, product type: lead.Product id: neu_unknown_ext, serial# unknown, product type: extension.Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, serial# unknown product type: implantable neurostimulator.Product id: 3389, lot# unknown, product type: lead.Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator.(b)(4).(b)(6).

Event Description

Additional information received reported that the pulmonary edemas (event 7) were not related to the devices.The reporter stated that there were no observed device malfunctions and the patients recovered well.Due to the additional information received, the following events are now captured in these additional manufacturing reports; any additional information received regarding these events will be reported in the following manufacturing reports: 5.Infection of hardware requiring explant: manufacturing report # 3007566237-2014-01047 6.Infection of hardware, no explant: manufacturing report # 3007566237-2014-01049 8.Sub-optimally placed unilateral leads: manufacturing report #'s 3007566237-2014-01051, 3007566237-2014-01052, 3007566237-2014-01053, and 3007566237-2014-01054 9.Sub-optimally placed bilateral leads: manufacturing report # 3007566237-2014-01055.

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 3600825
• MDR Text Key: 4193240
• Report Number: 3007566237-2014-00337
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P960009
• 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,Followup
• Report Date: 01/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2014
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2014
• 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