MAUDE Adverse Event Report: UNKNOWN LIBRA XP (ANS) STIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Fatigue (1849); Diaphoresis (2452)

Event Type  Injury  

Event Description

It was reported that the patient had experienced heavy sweating and fatigability, disproportionate to the undertaken physical effort, which the patient began complaining of about 8 months after the operation.The overall compulsion intensity according to the y-bocs was 45% lower after 8 months and 35% lower after 18 months compared to before the surgery.Despite the predominant mood improvement in the patient over the 18 month follow-up period, there were also periods of deterioration which required modification of the previously applied pharmacotherapy.Greatest deterioration in the patient's condition occurred 12 months from surgery.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LIBRA XP (ANS) STIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17529150
• MDR Text Key: 321138381
• Report Number: MW5136079
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1