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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 Problems Bacterial Infection (1735); Cellulitis (1768); Fever (1858); Nausea (1970); Skin Inflammation (2443)
Event Date 03/15/2018
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device components involved in the event: model#: sc-2218-50 serial #: (b)(4) description: linear st lead, 50cm model#: sc-4318 lot #: 21316416 description: clik x anchor it is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint devices could not be completed. A review of the device history records will be conducted. If there is any further relevant information from that review, a supplemental med watch will be filed.
 
Event Description
A report was received that the patient was hospitalized due to infection. Signs and symptoms were noted which includes fever, nausea and that the ipg and lead sites were very hot, red and inflamed. The patient was diagnosed with cellulitis. The physician believed that the infection was not device nor procedure related. The patient was administered with antibiotics.
 
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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 Key7394675
MDR Text Key104247572
Report Number3006630150-2018-01234
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
Report Date 04/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/13/2019
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 Received03/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/18/2017
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: 04/03/2018 Patient Sequence Number: 1
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