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-2316-50
Device Problems High impedance (1291); Kinked (1339); Cut In Material (2454)
Patient Problem Inadequate Pain Relief (2388)
Event Date 12/15/2015
Event Type  malfunction  
Manufacturer Narrative
Udi= (b)(4).Additional suspect medical device component involved in the event: model #: sc-2316-50, serial #: (b)(4), description: infinion1x16 perc lead kit-50 cm.Model #: sc-3400-30, serial #: (b)(4), description: infinion splitter 2x8 kit (30 cm).Model #: sc-4316, lot #: 16013535, description: next generation anchor kit-sterile.
 
Event Description
A report was received that several contacts were producing high impedances.The patient underwent a revision procedure wherein leads, lead splitters and clik anchor were replaced.No device malfunction suspected with the clik anchor.The physician felt that the clik anchor caused the malfunction of the leads.It was noted that the malfunction was somewhere between the lead splitters and leads.The patient was doing well post operatively.
 
Manufacturer Narrative
Sc-2316-50 (sn (b)(4)) device evaluation indicated that visual inspection revealed that the lead body was kinked 1 cm from the retention sleeve, where it appears the lead was sutured.X-ray inspection revealed severed cables at the kinked section of the lead.This appears to have been caused by fatigue possibly coupled with postural changes/movements.The completely severed cables were the reason for the high impedances observed.There were no exposed cables at the kinked section of the lead.Additionally, proximal contacts #1-#7 were separated and found in the associated splitter.The lead body was also cleanly cut 7.5 cm from the proximal end.The root cause of the proximal end damage was unknown.The clean cut damage was a result of a typical explant procedure and it was not considered a failure.Sc-2316-50 (sn (b)(4)) device evaluation indicated that visual inspection revealed that the lead body was kinked 1 cm from the retention sleeve, where it appears the lead was sutured.X-ray inspection revealed severed cables at the kinked section of the lead.This appears to have been caused by fatigue possibly coupled with postural changes/movements.The completely severed cables were the reason for the high impedances observed.There were no exposed cables at the kinked section of the lead.Additionally, proximal contacts #1-#6 were separated and found in the associated splitter.The lead body was also cleanly cut 7.5 cm from the proximal end.The root cause of the proximal end damage was unknown.The clean cut damage was a result of a typical explant procedure and it was not considered a failure.Sc-3400-30 (sn (b)(4)) device evaluation indicated that the complaint was not confirmed.X-ray inspection revealed contacts lodged in the connector stacks.The associated leads were found to be the source of the complaint.Sc-4316 (lot # 16013535) device evaluation indicated that visual inspection revealed one eyelet was fractured and exhibited missing silicon.The cause of the damage was not determined.Additional information was received that the missing silicone was removed from the patient's body.
 
Event Description
A report was received that several contacts were producing high impedances.The patient underwent a revision procedure wherein leads, lead splitters and clik anchor were replaced.No device malfunction suspected with the clik anchor.The physician felt that the clik anchor caused the malfunction of the leads.It was noted that the malfunction was somewhere between the lead splitters and leads.The patient was doing well post operatively.
 
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 Key5356022
MDR Text Key35490414
Report Number3006630150-2015-03469
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 12/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/30/2015
Device Model NumberSC-2316-50
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/17/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/09/2013
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 Age59 YR
-
-