MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE PRIMARY CELL IPG; DEEP BRAIN STIMULATOR

Model Number DB-1140

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

Patient Problems Headache (1880); Muscular Rigidity (1968); Pain (1994); Anxiety (2328); Palpitations (2467); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2018 (exact date is unknown).Phone: (b)(6).A review of the manufacturing documentation for the ipg revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.A review of the sterilization documentation for the device was found to be satisfactory.

Event Description

A report was received that the patient developed worsening parkinson¿s disease symptoms which were mild in severity.The patient was admitted, treated with medication, and the device was reprogrammed.The patient recovered and the event resolved, the patient was then discharged.The event was assessed as causally related to the study device stimulation and not related to the device or procedure.

Manufacturer Narrative

Additional information was received that detailed the patient symptoms and the hospitalization treatment.The patient experienced leg hypokinesia, unusually long off phases, stiffness in both arms, frontally accentuated bilateral headache radiating into the neck area, and tightness in the chest.Feelings of anxiety were associated with this episode, along with sweating and palpitations.During the admission the patient was observed to experience hypokinesia phase.Clinical examination during these phases showed a right-accentuated rigor, with bradykinesia and hypokinesia on the hand and the foot tapping and hand movements, and pain especially in the lower limbs when the patient was under psychological strain.The patient rapidly improved after administration of madopar lt, and stimulation was adjusted, medications were adjusted.

Event Description

A report was received that the patient developed worsening parkinson¿s disease symptoms which were mild in severity.The patient was admitted, treated with medication, and the device was reprogrammed.The patient recovered and the event resolved, the patient was then discharged.The event was assessed as causally related to the study device stimulation and not related to the device or procedure.

• Brand Name: VERCISE PRIMARY CELL IPG
• Type of Device: DEEP BRAIN STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 7526258
• MDR Text Key: 108656606
• Report Number: 3006630150-2018-01746
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: 150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/04/2017
• Device Model Number: DB-1140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 06/07/2018
• Supplement Dates FDA Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 58 YR