MAUDE Adverse Event Report: MEDTRONIC DBS

Model Number 7426

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Memory Loss/Impairment (1958); Disability (2371); Cognitive Changes (2551); Confusion/ Disorientation (2553); Test Result (2695)

Event Date 01/19/2004

Event Type  Injury  

Event Description

Bilateral dbs implanted for cervical dystonia (b)(6) 2004.Prior to dbs implantation, patient had "superior cognition" as evidenced from a pre-operative neuropsychiatric evaluation.Patient was fully employed at time of surgery, working as a (b)(6).Surgery did not improve or help cervical dystonia and in fact led to a severe decline in patient's mental status.Patient is unable to work, is totally disabled and scores (b)(6).Executive functioning continues to deteriorate.Patient diagnosed as having dementia.Surgery performed on (b)(6) 2004 shows no complications or adverse effects.One must assume the dbs device is cause of mental decline.

• Brand Name: DBS
• Type of Device: DBS
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 4924503
• MDR Text Key: 6049172
• Report Number: MW5044413
• Device Sequence Number: 1
• Product Code: MRU
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7426
• Patient Sequence Number: 1
• Treatment: DBS (CURRENTLY TURNED OFF); ARICEPT; NAMENDA
• Patient Outcome(s): Other; Disability
• Patient Age: 53 YR
• Patient Weight: 86