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 SPECTRA; 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 SPECTRA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1132
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Erosion (1750); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Pocket Erosion (2013); No Code Available (3191)
Event Date 01/15/2020
Event Type  Injury  
Event Description
A report was received that the patients ipg was beginning to protrude through the skin and was becoming red and painful.It was noted that the patient had an infection and inflammatory reaction due to other nervous system device, implant or graft.The patient was prescribed with medication for pain management and as prophylaxis against infection at the ipg site.
 
Manufacturer Narrative
Model number/catalog number: sc-2316-50 serial number: (b)(6).Batch/lot number: 18437628/18915135.Model/catalog description: infinion lead kit, 50 cm.Additional information was received that the patients infection was at the ipg site.The physician confirmed that it was not device or procedure related.The infection may be due to a poor surgical technique from a different physician.The patient was prescribed with antibiotics and underwent an explant procedure.The patient was doing well postoperatively.The explanted devices were not returned to bsn as they were discarded by the medical facility.
 
Event Description
A report was received that the patients ipg was beginning to protrude through the skin and was becoming red and painful.It was noted that the patient had an infection and inflammatory reaction due to other nervous system device, implant or graft.The patient was prescribed with medication for pain management and as prophylaxis against infection at the ipg site.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PRECISION SPECTRA
Type of Device
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key9684816
MDR Text Key178315889
Report Number3006630150-2020-00448
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729821526
UDI-Public08714729821526
Combination Product (y/n)N
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date09/27/2018
Device Model NumberSC-1132
Device Catalogue NumberSC-1132
Device Lot Number19765015
Was Device Available for Evaluation? No
Date Manufacturer Received02/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age79 YR
-
-