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

Model Number NEU_INS_STIMULATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Hemorrhage, Cerebral (1889); Dysphasia (2195); Cognitive Changes (2551); Confusion/ Disorientation (2553)

Event Date 02/07/2013

Event Type  Injury  

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 neu_unknown_lead, lot# unknown, product type: lead; product id neu_unknown_lead, lot# unknown, product type: lead; product id neu_ins_stimulator, serial # unknown, product type: implantable neurostimulator.(b)(4).

Event Description

Morishita, t., okun, m.S., burdick, a., jacobson, iv c.E., foote, k.D.2013.Cerebral venous infarction: a potentially avoidable complication of deep brain stimulation surgery.Neuromodulation 2013; 16: 407¿413.Doi: 10.1111/ner.12052 summary: despite numerous reports on the morbidity and mortality of deep brain stimulation (dbs), cerebral venous infarction has rarely been reported.We present four cases of venous infarct secondary to dbs surgery.The diagnosis of venous infarction was based on delayed onset of new neurologic deficits on postoperative day 1 or 2; significant edema surrounding the superficial aspect of the implanted lead, with or without subcortical hemorrhage on ct scan.Four cases (0.8% per lead, 1.3% per patient) of symptomatic cerebral venous infarction were identified out of 500 dbs lead implantation procedures between july 2002 and august 2009.All four patients had parkinson¿s disease.Their dbs leads were implanted in the subthalamic nucleus (n = 2), and the globus pallidus internus (n = 2).Retrospective review of the targeting confirmed that the planned trajectory passed within 3mm of a cortical vein in two cases for which contrast-enhanced preoperative magnetic resonance (mr) imaging was available.In the other two cases, contrasted targeting images were not obtained preoperatively.Cerebral venous infarction is a potentially avoidable, but serious complication.To minimize its incidence,we propose the use of high-resolution, contrast-enhanced, t1-weighted mr images to delineate cerebral venous anatomy, along with careful stereotactic planning of the lead trajectory to avoid injury to venous structures.Reported event: one (b)(6) female patient with parkinson¿s disease (pd) had a second lead implanted on the contralateral side six months after having a right subthalamic nucleus (stn) deep brain stimulation (dbs) lead implanted with good results.The reporter stated that the patient had been discharged on postoperative day 1 after an uncomplicated hospital course.The patient reportedly experienced aphasia and a decreased level of consciousness the evening following the second lead implantation.The patient¿s symptoms reportedly persisted through the following morning and the patient was then brought to the emergency room.The reporter stated that except for significant but incomplete expressive dysfluency and disorientation, the patient was neurologically intact.It was noted that a ct scan of the patient¿s head demonstrated cerebral edema and subcortical hemorrhage surrounding the superficial aspect of the dbs lead.The patient was reportedly managed conservatively by having the head of the patient¿s bed elevated to optimize venous return, controlling blood pressure to minimize secondary subcortical hemorrhage, administration of prophylactic anticonvulsants to diminish the known risk of seizure when subcortical hemorrhage is observed, avoiding dehydration to optimize blood rheology, avoiding steroids.It was noted that the patient was appropriately monitored and had adequate supervision.The patient¿s dysphasia reportedly improved over the next several days.It was noted that some of the confusion persisted for several weeks, but the patient¿s speech and cognition ultimately recovered completely.The reporter stated that the complication could clearly be attributed to inadequate avoidance of surface veins.It was noted that the patient experienced improved motor function with dbs despite the subacute postoperative complications.Further information has been requested; a supplemental report will be submitted if additional information is received.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported that the complication was not device-related.It was noted to be an issue of surgeon technique.The reporter stated that the device was not explanted and no malfunctions were observed.The reporter stated that the patient, despite periods of significant neurologic deficits that gradually resolved over the course of several weeks, ultimately derived substantial clinical benefit from deep brain stimulation (dbs) therapy.The reporter stated that it was unknown whether the patient's outcome would have been better without the venous infarction, but it was noted that the patient ended up in a substantially better state post-operatively than pre-operatively.It was noted that the patient fully recovered.

• 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: 3553041
• MDR Text Key: 19319273
• Report Number: 3007566237-2014-00038
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 02/06/2014
• 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): Other
• Patient Age: 00067 YR