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

Model Number NEU_UNKNOWN_LEAD

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

Patient Problems Muscle Weakness (1967); Dysphasia (2195)

Event Date 06/04/2014

Event Type  Injury  

Event Description

It was reported that the adverse event was right corona radiate infarct.It was noted that at the time of report it was unknown if the patient planned to complete deep brain stimulation (dbs) procedure.It was noted that the outcome was resolved without sequelae on (b)(6) 2014.It was noted that interventions included medical or non-surgical intervention including warfarin and phenylephrine infusion on (b)(6) 2014.It was noted that diagnostic methods included a nih stroke scale evaluation with a score of 5 and an mri without contrast showing no indications of stroke or hemorrhage on (b)(6) 2014.It was noted that and mri with contrast showed right corona radiate infarct a day later.It was noted that the etiology included surgery/anesthesia.It was noted that the event was not related to the device or therapy and was related to the implant procedure.It was noted that during lead placement the patient became sleepy, dysarthric with left facial droop and left upper extremity weakness.It was noted that the severity was severe.It was noted that the event resulted in in-patient hospitalization.It was noted that the event was a life threatening situation.Additional information was requested but was not available as of the date of this report.

Manufacturer Narrative

Product id: neu_unknown_ext, serial# unknown, implanted: (b)(6) 2014, product type: extension.(b)(4).

Event Description

Additional information received reported that the event occurred after the lead placement, but the leads were then removed once the patient started exhibiting symptoms.It was noted that the dbs had not been implanted in the patient.Additional information received reported that the site did not receive any device information.

• Brand Name: LEAD, UNKNOWN
• 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: 3976485
• MDR Text Key: 4634607
• Report Number: 3007566237-2014-02165
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_UNKNOWN_LEAD
• Device Catalogue Number: NEU_UNKNOWN_LEAD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2014
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 00073 YR