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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION MONTAGE MRI; SPINAL CORD STIMULATOR

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BOSTON SCIENTIFIC NEUROMODULATION PRECISION MONTAGE MRI; SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-1200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Reaction (2414)
Event Date 02/07/2018
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device components involved in the event: model #: sc-2408-56 serial (b)(4) description: avista mri percutaneous lead kit, 56 cm.
 
Event Description
A report was received that the patient had developed eczema.The dermatologist believed it may be due to the makeup of the scs system.The patient was prescribed with methylprednisolone and everything was under control.
 
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Brand Name
PRECISION MONTAGE MRI
Type of Device
SPINAL 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 Key7447371
MDR Text Key106064901
Report Number3006630150-2018-01326
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729905943
UDI-Public08714729905943
Combination Product (y/n)N
PMA/PMN Number
030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial
Report Date 04/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date03/28/2019
Device Model NumberSC-1200
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/30/2018
Initial Date FDA Received04/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/04/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age68 YR
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