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 SPECTRA WAVEWRITER; 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 SPECTRA WAVEWRITER; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1160
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Inflammation (1932); Swelling (2091); No Code Available (3191)
Event Date 07/22/2019
Event Type  Injury  
Manufacturer Narrative
Model number/catalog number: sc-2218-50.Serial number: (b)(4).Batch/lot number: 16121539/ 16065047.Model/catalog description: linear st lead kit 50 cm.
 
Event Description
It was reported that the patient had an infection.The patient underwent an explant procedure.
 
Manufacturer Narrative
Additional information was received that the patient infection was on the battery site.Symptoms of puffiness and swelling were noted.The patient was placed on antibiotics.
 
Event Description
It was reported that the patient had an infection.The patient underwent an explant of the scs system.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SPECTRA WAVEWRITER
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 Key10038744
MDR Text Key190327037
Report Number3006630150-2020-02011
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729951254
UDI-Public08714729951254
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 06/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date05/26/2021
Device Model NumberSC-1160
Device Catalogue NumberSC-1160
Device Lot Number355666
Was Device Available for Evaluation? No
Date Manufacturer Received05/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age63 YR
-
-