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®; 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®; SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-2316-50
Device Problems Bent (1059); Break (1069); Fracture (1260); High impedance (1291); Kinked (1339); Material Separation (1562)
Patient Problem Inadequate Pain Relief (2388)
Event Date 11/05/2015
Event Type  malfunction  
Manufacturer Narrative
Additional suspect medical device components involved in the event: model #: sc-2316-50 serial #: (b)(4) description: infinion 1x16 perc lead kit-50 cm model #: sc-3400-30 serial #: (b)(4) description: infinion splitter 2x8 kit (30cm).
 
Event Description
A report was received that the patient was experiencing inadequate stimulation.High impedances were noted.The patient underwent a procedure, during which, the physician explanted the leads and the splitters.Following the procedure the patient had adequate coverage and was reportedly doing well.
 
Manufacturer Narrative
(b)(4).Additional suspect medical device components involved in the event: model #: sc-2316-50, serial #: (b)(4), description: infinion 1x16 perc lead kit-50 cm; model #: sc-3400-30, serial #: (b)(4), description: infinion splitter 2x8 kit(30cm); model #sc-2316-50 (sn (b)(4)): device evaluation indicated that the complaint had been confirmed.Visual (microscope) and x-ray inspection of the lead revealed that multiple cables were completely broken at the bent/kinked location of the lead.The bent/kinked location was 1 cm from the set screw mark of the clik anchor.There were no exposed cables at the clik site fracture locations.The broken cables resulted in the reported complaint of high impedance.Additionally, visual inspection revealed that the top seven electrodes were separated from the distal end.Electrodes 1-7 were not returned.It appeared that tensile force was applied on the top seven electrodes resulting in fractured cable welds and its separation from the distal end.The returned portion of the distal end was fractured in multiple sections and several cables were exposed.Model # sc-2316-50 (sn (b)(4)): device evaluation indicated that the complaint had been confirmed.Visual (microscope) and x-ray inspection of the lead revealed that multiple cables were completely broken at the bent/kinked location of the lead.The bent/kinked location was 1 cm from the set screw mark of the clik anchor.There were no exposed cables at the clik site fracture locations.The broken cables resulted in the reported complaint of high impedance.Model # sc-3400-30, sn (b)(4): device evaluation indicated that the complaint was not verified.A test infinion lead was inserted into the splitters connector without any anomalies.Devices exhibited normal device characteristics.Additional information was received that the top seven electrodes that were separated were not left inside patient's body.
 
Event Description
A report was received that the patient was experiencing inadequate stimulation.High impedances were noted.The patient underwent a procedure, during which, the physician explanted the leads and the splitters.Following the procedure the patient had adequate coverage and was reportedly doing well.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PRECISION®
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 Key5316426
MDR Text Key34050441
Report Number3006630150-2015-03071
Device Sequence Number1
Product Code LGW
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
Report Date 11/05/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/30/2016
Device Model NumberSC-2316-50
Other Device ID NumberM365SC2316500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/05/2015
Initial Date FDA Received12/21/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/13/2014
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 Age78 YR
-
-