MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION LEAD, UNKNOWN; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number NEU_UNKNOWN_LEAD

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

Patient Problems Death (1802); Intracranial Hemorrhage (1891); Swelling (2091); Brain Injury (2219); Loss of consciousness (2418)

Event Type  Death  

Event Description

It was reported that the patient had undergone a phase 1 deep brain stimulator lead implant on (b)(6) 2015.The patient was being implanted to treat dystonia.The two leads had been implanted with no complications and the patient had returned home on (b)(6) following lead implant with no issues.On (b)(6) 2015 the patient had laid down for a nap and would not wake up.The patient was then airlifted to the hospital where a mri was done that had indicated bleeding on the brain at the tip of one lead.The patient was intubated and kept in an induced coma.Swelling on the patient¿s brain had continued.On (b)(6) 2015, surgical procedure was done to remove one lead and to remove a section of the skull to attempt to reduce swelling.Despite attempts the swelling had continued and was unable to be controlled.It had been determined that the patient had suffered unrecoverable brain damaged.The patient had never regained consciousness since being unresponsive on (b)(6) 2015.The patient¿s family had decided to remove life support and the ventilator.Patient passed away on (b)(6) 2015.The healthcare professional had indicated that they were unable to determine what had happened in this case.

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_lead, serial# unknown, implanted: (b)(6) 2015, product type: lead.Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator.Product id: neu_unknown_ext, serial# unknown, product type: extension.(b)(4).

• Brand Name: LEAD, UNKNOWN
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• 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: 4874636
• MDR Text Key: 6061095
• Report Number: 3007566237-2015-01793
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2015
• 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): Death; Hospitalization; Other; Required Intervention