MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION; 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)

Patient Problems Intracranial Hemorrhage (1891); Muscle Spasm(s) (1966); Neurological Deficit/Dysfunction (1982); Pain (1994); Dyskinesia (2363)

Event Date 07/01/2004

Event Type  Injury  

Manufacturer Narrative

This value is the average age of the patients reported in the article as specific patients could not be identified.Date of event: please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.Note that this regulatory report involves two different publications of the same literature article, one which was published two years after (2006) the initial 2004 publication, and which had additional follow-up information, but involved the same patient cohort, contained all the adverse events which had occurred at the time of the initial 2004 publication, and was in all other ways the same.Concomitant medical products: product id 3387, product type: lead.Product id neu_unknown_ext, product type: extension.Product id 3387, product type: lead.Product id neu_unknown_ext, product type: extension.Product id 3387, product type: lead.Product id 3387, product type: lead.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

Starr, p.A., turner, r.S., rau, g., lindsey, n., heath, s., volz, m., ostrem, j.L., marks, w.J.Microelectrode-guided implantation of deep brain stimulators into the globus pallidus internus for dystonia: techniques, electrode locations, and outcomes.Neurosurg focus.2004.17 (1):e4.Summary: deep brain stimulation (dbs) of the globus pallidus internus (gpi) is a promising new procedure for the treatment of dystonia.The authors present their technical approach for placement of electrodes into the gpi in awake patients with dystonia, including the methodology used for electrophysiological mapping of the gpi in the dystonic state, clinical outcomes and complications, and the location of electrodes associated with optimal benefit.Reported events for unidentified patients: a patient with dbs of the gpi for dystonia experienced an asymptomatic hemorrhage of less than 0.2 milliliters; a patient with dbs of the gpi for cervical dystonia reportedly had to return to the operating room for hardware exploration, where the information provided suggests it was discovered that both extension connectors had migrated from the parietal area to the cervical area, and one of the leads had fractured 1 centimeter proximal to the connector.This was managed by stereotactic replacement of the broken lead and revision of the extension connectors to place them back in the appropriate parietal location; a patient with dbs of the gpi for cervical dystonia had to return to the operating room for exploration of a painful extension connector; 2 patients with dbs of the gpi for dystonia had a lead that required surgical repositioning because of suboptimal initial placement.These leads were noted to be too close to the corticobulbar tract, resulting in an inability to activate the device fully without facial contraction; 1 patient with dbs of the gpi for dystonia had a lead that required surgical repositioning because of suboptimal initial placement.The lead was associated with significant benefit in contralateral proximal leg dystonia, but the lead was found to be ¿relatively lateral,¿ within the globus pallidus externus (gpe) rather than the gpi resulting in persistent foot inversion as well as stimulation-induced dyskinesia at therapeutic settings.Foot dystonia improved slightly and stimulation-induced dyskinesia disappeared with placement of the lead 2 mm closer to the midline.All patients were implanted with model 3387 leads and either model 7426 or 7428 neurostimulators.It was not possible to ascertain any additional specific device information from the article, such as serial numbers, or to match the reported event with any previously reported event.

Manufacturer Narrative

Additional review found that the originally sent event description contained a typographical error.Supplemental initiated to note correction of ".Less than 0.2 milliliters" to ".Greater than 0.2 milliliters.".

Event Description

A patient with dbs of the gpi for dystonia experienced an asymptomatic hemorrhage of greater than 0.2 milliliters.

• 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: 5664947
• MDR Text Key: 45470349
• Report Number: 3007566237-2016-02043
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/17/2016

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: 04/21/2016
• Initial Date FDA Received: 05/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/17/2016
• 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): Other; Required Intervention
• Patient Age: 58 YR