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 Hemorrhage, Cerebral (1889); Seizures (2063)

Event Date 05/29/2012

Event Type  Injury  

Event Description

Piacentino, m., zambon, g., pilleri, m., bartolomei, l.Comparison of the incidence of intracranial hemorrhage in two different planning techniques for stereotactic electrode placement in the deep brain stimulation.J.Neurosurg.Sci.2013;57(1):63-67.Summary: intracranial hemorrhage is an infrequent but potentially devastating complication associated with the placement of electrodes for deep brain stimulation (dbs).The objective of this retrospective review is to compare the risk of hemorrhage before and after the introduction of image-guided neuronavigation for the implant of electrodes for dbs.We reviewed all dbs implant performed at our institute between 1998 and 2010.In 63 of the 106 patients, the targeting was based on ventriculography and merge of ct/mri.After 2006, in the latter 43 procedures, we introduced targeting based on the merging of angio ct and mri.In both implant techniques, microelectrode recording (mer) was used to better define the target.All dbs procedures were performed by a single surgeon (m.P.).Patients had postoperative imaging (mri or en 4-24 h following surgery.In the group of patients implanted with the first targeting technique, 3 hematomas occurred and all of them solved with sequelae (one residual weakness and two hemiplegias.) after the introduction of neuronavigator, 2 hemorrhages occurred, one solved without sequelae while the second resulted in epileptic seizures.Although the incidence of hemorrhage occurred before and after the use of neuronavigation is the same, the severity is lower in the neuronavigated procedures.Targeting based on the merging of ct angiography and mri tl/t2 seemed to increase the safety of the lead placement reducing the risk of sequelae related to bleeding.The use of mer was not found to be correlated with an increased hemorrhage rate.Reported event: one (b)(6) patient with parkinson¿s disease experienced a cortical hemorrhage following deep brain stimulation (dbs) lead implant.The reporter stated that the patient experienced epileptic syndrome as a result of the hemorrhage.It was noted that the patient¿s seizures were well controlled by medical treatment.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.Product id: neu_unknown_lead, lot# unknown, product type: lead.(b)(4).

• 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: 3599579
• MDR Text Key: 4089191
• Report Number: 3007566237-2014-00332
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: Health Professional
• Type of Report: Initial
• Report Date: 01/16/2014

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?: No
• 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
• Date Manufacturer Received: 01/16/2014
• 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; Required Intervention
• Patient Age: 00030 YR