Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 NOVI; SPINAL CORD STIMULATOR
  • 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 NOVI; SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-1140
Device Problem Device Stops Intermittently (1599)
Patient Problem Pain (1994)
Event Date 08/27/2017
Event Type  Injury  
Event Description
A report was received that the patient had pain in the ipg pocket site and their ipg turns itself off several times.X-rays were taken and a revision procedure was performed in which the ipg was explanted.Database analysis of the ipg was performed, the analysis showed four magnet resets, the time and dates of the resets are unknown.The impedance measurements were observed to be within a normal range.Based on the analysis, the device appears to be working as expected.
 
Manufacturer Narrative
Ipg sc-1140 (b)(4): the complaint was not confirmed.The device passed all required tests performed and exhibits normal device characteristics.
 
Event Description
A report was received that the patient had pain in the ipg pocket site and their ipg turns itself off several times.X-rays were taken and a revision procedure was performed in which the ipg was explanted.Database analysis of the ipg was performed, the analysis showed four magnet resets, the time and dates of the resets are unknown.The impedance measurements were observed to be within a normal range.Based on the analysis, the device appears to be working as expected.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PRECISION NOVI
Type of Device
SPINAL 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 Key6973483
MDR Text Key90088838
Report Number3006630150-2017-04317
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729897835
UDI-Public08714729897835
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/12/2018
Device Model NumberSC-1140
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/26/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/16/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age24 YR
-
-