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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 Hemorrhage/Bleeding (1888); Muscle Spasm(s) (1966); Seizures (2063)
Event Date 05/02/2017
Event Type  Injury  
Event Description
A report was received that the patient had experienced internal bleeding, muscle spasms, and seizures since being implanted with the spinal cord stimulator. No further information was provided.
 
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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 Key8636729
MDR Text Key145950258
Report Number3006630150-2019-02420
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
Type of Report Initial
Report Date 05/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2019
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 Received05/02/2019
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: 05/23/2019 Patient Sequence Number: 1
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