MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION

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

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Unspecified Infection (1930); Undesired Nerve Stimulation (1980); Neurological Deficit/Dysfunction (1982); Pain (1994); Paralysis (1997); Injury (2348); Cognitive Changes (2551); Weight Changes (2607); Nervous System Injury (2689); No Code Available (3191)

Event Date 06/26/2019

Event Type  Injury  

Event Description

A report was received that after being implanted with a stimulator the patient suffered from various complications.It was stated that the leads into the back of the brain were too short and every time the patient turned his head he was jolted causing pain.Additionally, due to the inability to move his head, the patient would lose his balance.The loss of balance coupled with reported sciatic damage in the leg caused the patient to fall.This fall caused the battery in his back to rupture which led to a life-threatening infection that never cleared up.The patient underwent an explant procedure to remove the device and suffered from further complications including several incidents of cardiac arrest, brain damage, cognition loss, worsened ability to control his blood sugar as he was diabetic, and eventually lost nearly all function of his hands and legs.Eventually, the patient had dropped to 98 pounds and became a completely dependent invalid.Ultimately, the patient passed away two years and two months after having the stimulator implanted.Despite efforts requesting additional information, nothing further has been reported.

• Manufacturer (Section D): 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: 8805213
• MDR Text Key: 151551319
• Report Number: 3006630150-2019-03686
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention; Disability