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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 Problems Charging Problem (2892); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 12/08/2017
Event Type  Malfunction  
Event Description

A report was received that the patient underwent a revision procedure for an unknown reason.

 
Manufacturer Narrative

Additional information was received that no device malfunction was suspected. The explanted device was not returned to bsn as it was discarded by the medical facility.

 
Event Description

A report was received that the patient underwent a revision procedure for an unknown reason.

 
Manufacturer Narrative

Field in the initial mdr should have been: (b)(6) 2017. Additional information was received that the patient was having difficulty charging the ipg. The patient underwent an ipg replacement procedure and was doing well postoperatively. The explanted device was not returned to bsn.

 
Event Description

A report was received that the patient underwent a revision procedure for an unknown reason.

 
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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 Key7155564
MDR Text Key96072449
Report Number3006630150-2017-05531
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN Number030017
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 01/24/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/01/2012
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 Received01/10/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/10/2011
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: 12/29/2017 Patient Sequence Number: 1
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