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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION

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BOSTON SCIENTIFIC NEUROMODULATION Back to Search Results
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.
 
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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 Key8805213
MDR Text Key151551319
Report Number3006630150-2019-03686
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
PMA/PMN Number
P030017
Number of Events Reported1
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 Received07/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2019
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 Treatment Data
Date Received: 07/18/2019 Patient Sequence Number: 1
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