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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC NEUROMODULATION PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Seizures (2063); Complaint, Ill-Defined (2331); No Code Available (3191)
Event Date 11/13/2019
Event Type  Injury  
Manufacturer Narrative
The device was not returned to bsn. A review of the manufacturing documentation for the ipg revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.
 
Event Description
A report was received that the patient recently developed some medical issues, and was experiencing seizures, and bladder control problems. The patient was being kept sedated at the hospital with the stimulation turned off. The physician performed brain scan imaging and was not able to determine the cause of the seizures, however, the physician confirmed after reviewing images there was no concerns with lead movement or positioning of the device, and believes the event was not device related.
 
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Brand NamePRECISION MONTAGE MRI
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 CORPORATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key9427717
MDR Text Key169561876
Report Number3006630150-2019-07133
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 12/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/18/2019
Device Model NumberSC-1200
Device Catalogue NumberSC-1200
Device Lot Number21148035
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 Received11/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/18/2017
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: 12/06/2019 Patient Sequence Number: 1
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