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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA® SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-1132
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Edema (1820)
Event Date 01/10/2017
Event Type  Injury  
Event Description
A report was received that the patient¿s pocket site was swollen. The patient underwent a procedure wherein the fluid at the ipg site was drained.
 
Manufacturer Narrative
Additional information was received that the patient will have an injection. If the pocket site is still swollen after the injection, the pocket site will be drained.
 
Event Description
A report was received that following an implant procedure, the patient¿s pocket site was swollen. The patient will undergo a procedure wherein the fluid at the ipg site will be drained.
 
Manufacturer Narrative
Additional information was received that the patient's ipg site was no longer swollen and the incision was healed correctly. It was also noted that the patient had a cervical epidural injection for the pain unrelated to stimulator and there will be no further course of action.
 
Event Description
A report was received that following an implant procedure, the patient¿s pocket site was swollen. The patient will undergo a procedure wherein the fluid at the ipg site will be drained.
 
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Brand NamePRECISION SPECTRA®
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 Key6284192
MDR Text Key65998517
Report Number3006630150-2017-00157
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,Followup
Report Date 01/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2018
Device Model NumberSC-1132
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 Received02/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/05/2016
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: 01/27/2017 Patient Sequence Number: 1
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