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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPINAL CORD STIMULATOR

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BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPINAL CORD STIMULATOR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Pain (1994)
Event Date 02/26/2017
Event Type  Injury  
Event Description
A report was received per social media that the patient's scs had shifted to the spine. It was also noted that it protruded from the patient's back and was pressing on the nerves which caused more pain. It was also reported that the patient's toes turned black from nerve damage and the toe nails fell off.
 
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Brand NamePRECISION
Type of DeviceSPINAL CORD 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 Key6407990
MDR Text Key70055379
Report Number3006630150-2017-00895
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
PMA/PMN Number
030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Patient
Type of Report Initial
Report Date 02/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2017
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2017
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: 03/15/2017 Patient Sequence Number: 1
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