MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ITREL II; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 7424

Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927)

Patient Problems Edema (1820); Unspecified Infection (1930); Neurological Deficit/Dysfunction (1982); Paresis (1998); Seroma (2069)

Event Date 12/18/2001

Event Type  Injury  

Manufacturer Narrative

Date of event: please note this date is based off of the article¿s publication date as the specific event date was not provided in the published literature.It was not possible to ascertain specific device information from the article or to match the reported events 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.The main component of the system from the first event; other applicable components are: product id: 3387, product type: lead.Product id: 7424, product type: implantable neurostimulator.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Bereznai, b., steude, u., seelos, k., botzel, k.Chronic high-frequency globus pallidus internus stimulation in different types of dystonia: a clinical, video, and mri report of six patients presenting with segmental, cervical, and generalized dystonia.Movement disorders.2002.17:1 (138¿144).Doi 10.1002/mds.1250 summary: the results of deep brain stimulation (dbs) of the globus pallidus internus (gpi) in six patients with generalized, focal, and segmental dystonia are presented.Reported events: one dystonia patient experienced ¿sermoa with subsequent infection of the subclavicular pocket¿ which ¿required temporary removal of the generator.¿ two dystonia patients experienced ¿4-day-long brachiofacial hemiparesis¿ that was ¿surgery-related.¿ it was further reported the patients had experienced ¿transient postoperative hemiparesis.¿ it was stated the events were ¿presumably due to local edema impinging on the internal capsula (ic).One dystonia patient experienced their stimulator ¿accidentally switch off.¿ it was further reported the patient ¿then complained of a reoccurrence of dystonia approximately 4-5 hours after passing a metal detector at the airport.¿ it was noted the patient¿s ¿symptoms resolved again approximately 4 hours after stimulation was switched on.¿ one dystonia patient experienced their stimulator ¿accidentally switch off.¿ it was further reported the patient ¿then complained of a reoccurrence of dystonia¿ approximately 4-5 hours ¿after using an electrical machine (professional kitchen machine).¿ it was noted the patient¿s ¿symptoms resolved again approximately 4 hours after stimulation was switched on.¿ it was reported that a ¿stimulator failed due to accidental magnetic influence.¿.

• Brand Name: ITREL II
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5664380
• MDR Text Key: 45442870
• Report Number: 3007566237-2016-02035
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7424
• Device Catalogue Number: 7424
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2016
• 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