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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 10/18/2013
Event Type  Injury  
Manufacturer Narrative
Udi
=
(b)(4).
 
Event Description
A report was received that the patient had sciatic nerve damage. The patient underwent an ipg explant procedure. The patient was doing well post operatively.
 
Manufacturer Narrative
Additional information was received that the bsn sales representative did not remember the patient or having type of problem with any implants.
 
Event Description
A report was received that the patient had sciatic nerve damage. The patient underwent an ipg explant procedure. The patient was doing well post operatively.
 
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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 Key5954363
MDR Text Key54873074
Report Number3006630150-2013-02508
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 10/21/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/01/2013
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 Received09/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/19/2011
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: 09/15/2016 Patient Sequence Number: 1
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