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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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BOSTON SCIENTIFIC NEUROMODULATION PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1110-02
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 07/02/2018
Event Type  Injury  
Manufacturer Narrative
The explanted device was not returned to bsn as it was kept by the medical facility.
 
Event Description
A report was received that the patient was experiencing liver issues. The physician believed that the symptom was device related. The patient underwent an ipg replacement procedure. No device malfunction was suspected. The patient was doing well postoperatively.
 
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Brand NamePRECISION
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC NEUROMODULATION
25129 rye canyon loop
,
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
,
valencia, CA 91355
6619494863
MDR Report Key7737497
MDR Text Key115643193
Report Number3006630150-2018-60431
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/01/2014
Device Model NumberSC-1110-02
Device Catalogue NumberSC-1110-02
Device Lot Number15730903
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 Received07/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/27/2012
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: 07/31/2018 Patient Sequence Number: 1
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