MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED EL; PUMP, INFUSION, IMPLANTED, PROGRAMABLE

Model Number 8637-20

Device Problem Inaccurate Delivery (2339)

Patient Problems Stroke/CVA (1770); Death (1802); Seizures (2063); Loss of Vision (2139)

Event Date 02/22/2014

Event Type  Death  

Event Description

My mom has pump replaced with synchromed el had problems right after surgery, hours after receiving first fill she seized and stroked 21 days, as no one would listen they continued to administer narcan and i was explaining to them it was a continuous pump.Long story short my mother had posterior reversible and encephalopathy syndrome that did not reverse bilateral optical infarcts causing total blindness.This lead to her death! i had called medtronic's numerous times during this.When my mother was in the hospital they came out said nothing was wrong with the pump and left, i knew this was the pump or the contents of it.My mother is dead!.

• Brand Name: SYNCHROMED EL
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 8469546
• MDR Text Key: 140542837
• Report Number: MW5085376
• Device Sequence Number: 0
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Model Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Disability
• Patient Age: 66 YR