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

Model Number NEU_UNKNOWN_LEAD

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

Patient Problems Headache (1880); Muscle Weakness (1967); Seroma (2069)

Event Date 03/02/2015

Event Type  Injury  

Event Description

It was reported there was a subdural hygroma without mass effect.The patient had bilateral leads placed and the stimulator was scheduled to be placed later in (b)(6) 2015.The patient experienced a headache with bilateral leg weakness.The patient was observed in emergency department overnight.A ct scan with contrast revealed a small amount of extra axial fluid of simple density overlying the vertex.It was likely a subdural hygroma without mass effect.The etiology was the surgery/anesthesia and was unlikely related to the device or therapy and possibly related to the implant procedure.The event resulted in in-patient hospitalization.Refer to manufacturer report # 3007566237-2015-00790 the patient is implanted with bilateral leads.

Manufacturer Narrative

Concomitant: product id neu_unknown_lead, implanted: 2015-(b)(6), product type lead.(b)(4).

• Brand Name: UNKNOWN LEAD
• 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: 4638119
• MDR Text Key: 5597999
• Report Number: 3007566237-2015-00791
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• 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: 03/04/2015
• 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