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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
Model Number SC-1110-02
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Nerve Damage (1979)
Event Date 04/11/2018
Event Type  Injury  
Event Description
A report was received that the patient was asking how long the implant would last. The patient was scheduled for back surgery due to severe nerve damage. The physician had told the patient that might have a revision procedure.
 
Manufacturer Narrative
Additional information was received that the patient underwent decompression fusion which resolved all severe pain symptoms. The patient reported scs was functioning better.
 
Event Description
A report was received that the patient was asking how long the implant would last. The patient was scheduled for back surgery due to severe nerve damage. The physician had told the patient that might have a revision procedure.
 
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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 Key7480210
MDR Text Key107131093
Report Number3006630150-2018-01518
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/01/2014
Device Model NumberSC-1110-02
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/26/2012
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: 05/02/2018 Patient Sequence Number: 1
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