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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 Material Protrusion/Extrusion (2979)
Patient Problems Pain (1994); Pocket Erosion (2013); Discomfort (2330)
Event Date 05/26/2017
Event Type  Injury  
Manufacturer Narrative
Additional information was received that the physician believed it was just a general discomfort and did not tell anything about the skin breakage.
 
Event Description
A report was received that the patient was experiencing increased pain at the ipg site. It was noted that the ipg appeared to be rotated with the superior aspect of it protruding out through the skin. The patient will undergo a revision procedure wherein the ipg will be moved to the abdominal area.
 
Event Description
A report was received that the patient was experiencing increased pain at the ipg site. It was noted that the ipg appeared to be rotated with the superior aspect of it protruding out through the skin. The patient will undergo a revision procedure wherein the ipg will be moved to the abdominal area.
 
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Brand NamePRECISION MONTAGE MRI
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 Key6716890
MDR Text Key107003399
Report Number3006630150-2017-02578
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 06/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/23/2019
Device Model NumberSC-1200
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 Received08/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/28/2017
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: 07/17/2017 Patient Sequence Number: 1
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