• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Unspecified Infection (1930); Sepsis (2067); No Code Available (3191)
Event Date 08/22/2018
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device components involved in the event: model #: sc-2408-56; sn #: (b)(4); description: avista mri perc lead kit, 56 cm.
 
Event Description
A report was received that the patient experienced sepsis one week after the implant procedure. The patient may undergo a procedure to amputate the right lower limb.
 
Manufacturer Narrative
Additional information was received that the patient experienced a resistant bacterial infection. The patient underwent a procedure to amputate the right lower leg and was administered antibiotics. The physician assessed the infection was not device related, and that the patient had a repeated recurrence, and remission of osteomyelitis from half a year ago. The patient was doing well postoperatively.
 
Event Description
A report was received that the patient experienced sepsis one week after the implant procedure. The patient may undergo a procedure to amputate the right lower limb.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 CLONMEL LIMITED
cashel road
,
clonmel
EI
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
,
valencia, CA 91355
6619494863
MDR Report Key7878589
MDR Text Key120335667
Report Number3006630150-2018-60895
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/19/2020
Device Model NumberSC-1200
Device Catalogue NumberSC-1200
Device Lot Number355132
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 Received09/18/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/14/2018 Patient Sequence Number: 1
-
-