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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 Problems Overheating of Device (1437); Charging Problem (2892)
Patient Problems Pain (1994); Burning Sensation (2146)
Event Date 01/31/2022
Event Type  Injury  
Event Description
It was reported that the ipg would not charge properly and charging was painful for the patient. It was noted that the patient experienced burning sensation when turning on the ipg after the non-device related procedure. The patient underwent an ipg replacement procedure and was doing well postoperatively. The explanted ipg will not be returned.
 
Manufacturer Narrative
Exact date unknown, event occurred prior to fusion surgery last (b)(6) 2022.
 
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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 Key14522156
MDR Text Key292807413
Report Number3006630150-2022-02537
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729905943
UDI-Public08714729905943
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/09/2019
Device Model NumberSC-1200
Device Catalogue NumberSC-1200
Device Lot Number20377594
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2017
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: 05/27/2022 Patient Sequence Number: 1
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