• 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 LINEAR 3-6 LEAD 70 CM 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 LINEAR 3-6 LEAD 70 CM SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-2366-70
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Dizziness (2194)
Event Type  Injury  
Manufacturer Narrative
Date of event: (b)(6) 2017 (exact date is unknown) additional suspect medical device component involved in the event: model: sc-2366-70 serial: (b)(6), description: linear 3-6 lead, 70cm.
 
Event Description
A report was received that the patient experienced dizziness when the stimulation is on and off. The patient was previously diagnosed with tinnitus prior to the implantation of the device. The lead has migrated, and the patient will undergo a lead revision procedure wherein the lead will be repositioned.
 
Manufacturer Narrative
Correction to initial mdr in fields: b6 and b7 additional information was received that per the physicians assessment the patients symptoms were not due to lead migration. No device malfunction is suspected.
 
Event Description
A report was received that the patient experienced dizziness when the stimulation is on and off. The patient was previously diagnosed with tinnitus prior to the implantation of the device. The lead has migrated, and the patient will undergo a lead revision procedure wherein the lead will be repositioned.
 
Manufacturer Narrative
Additional information was received that there is no is no scheduled course of action. A review of the manufacturing documentation for the leads revealed that no anomalies or deviations potentially related to the event occurred during manufacturing. A review of the sterilization documentation for the devices was found to be satisfactory.
 
Event Description
A report was received that the patient experienced dizziness when the stimulation is on and off. The patient was previously diagnosed with tinnitus prior to the implantation of the device. The lead has migrated, and the patient will undergo a lead revision procedure wherein the lead will be repositioned.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLINEAR 3-6 LEAD 70 CM
Type of DeviceSPINAL 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 Key7507800
MDR Text Key108025138
Report Number3006630150-2018-01669
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/25/2019
Device Model NumberSC-2366-70
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 Received07/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/11/2018 Patient Sequence Number: 1
-
-