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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 Nerve Damage (1979); Pain (1994); Weakness (2145)
Event Date 08/19/2018
Event Type  Injury  
Event Description
A report was received via social media that a non confirmed patient was experiencing permanent nerve damage, more pain and weakness on the left side due to spinal cord stimulator (scs) system. It was noted that the patient could no longer work. No further information could be obtained.
 
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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 Key7879338
MDR Text Key120376873
Report Number3006630150-2018-60908
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 consumer,other
Reporter Occupation
Type of Report Initial
Report Date 09/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2018
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: 09/14/2018 Patient Sequence Number: 1
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