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; 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 SPECTRA; SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-3138-25
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Pain (1994)
Event Date 03/01/2018
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device component involved in the event: model#: sc-3138-25, serial#: (b)(4), description: scs phiii ext 25cm.
 
Event Description
A report was received that the patient was experiencing pain at the midline incision site that was aggravated when the stimulation was turned high.Swelling was also noted at the incision site.The physician believed that the symptoms were due to the extension leads.The patient will undergo a lead extension revision procedure.
 
Manufacturer Narrative
Additional information was received that there will be no further course of action at this time.
 
Event Description
A report was received that the patient was experiencing pain at the midline incision site that was aggravated when the stimulation was turned high.Swelling was also noted at the incision site.The physician believed that the symptoms were due to the extension leads.The patient will undergo a lead extension revision procedure.
 
Manufacturer Narrative
Additional information was received that the patient will undergo a lead replacement procedure.
 
Event Description
A report was received that the patient was experiencing pain at the midline incision site that was aggravated when the stimulation was turned high.Swelling was also noted at the incision site.The physician believed that the symptoms were due to the extension leads.The patient will undergo a lead extension revision procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PRECISION SPECTRA
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 Key7360537
MDR Text Key103129039
Report Number3006630150-2018-01125
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729760542
UDI-Public08714729760542
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 Physician
Type of Report Initial,Followup,Followup
Report Date 05/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date08/09/2019
Device Model NumberSC-3138-25
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/16/2017
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 Age35 YR
-
-