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 INFINION CX; 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 INFINION CX; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-2317-70
Device Problems High impedance (1291); Unexpected Therapeutic Results (1631)
Patient Problem Inadequate Pain Relief (2388)
Event Date 04/04/2022
Event Type  Injury  
Event Description
It was reported that the spinal cord stimulation (scs) patient experienced loss of adequate pain relief.High impedance readings were discovered on several contacts of both leads.Reprogramming attempts were unsuccessful at recapturing adequate pain relief.Therefore, the patient underwent a lead revision procedure wherein both leads were explanted and replaced with a paddle lead.The patient is expected to fully recover postoperatively.
 
Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: scs-linear leads; upn: m365sc2317700; model: sc-2317-70; serial: (b)(4); batch: (b)(4).Product family: scs-lead fixation; upn: m365sc43180; model: sc-4318; serial: n/a; batch: 24856289.
 
Event Description
It was reported that the spinal cord stimulation (scs) patient experienced loss of adequate pain relief.High impedance readings were discovered on several contacts of both leads.Reprogramming attempts were unsuccessful at recapturing adequate pain relief.Therefore, the patient underwent a lead revision procedure wherein both leads were explanted and replaced with a paddle lead.The patient is expected to fully recover postoperatively.
 
Manufacturer Narrative
Analysis of the returned leads sc-2317-70 serial numbers (b)(6) and (b)(6), revealed through visual and x-ray inspection, that the leads were bent/kinked 2 cm from the set screw mark of the clik x anchor and multiple cables were completely broken at this location.There are no exposed cables at the fracture location.Laboratory analysis determined that the leads became bent/kinked after exiting the clik x anchor, exposing the bent location to excessive mechanical force or movement that caused the cables to fracture at the anchor point.Based on all available information, engineers concluded that the high impedance measurements resulting in inadequate stimulation were caused by lead fracture.The leads became bent after exiting the clik x anchors which exposed the bent locations to excessive mechanical force or movement that caused the lead cables to fracture.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INFINION CX
Type of Device
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
road 698, lot no. 12
dorado PR 00646 -260
*   00646-2602
Manufacturer Contact
erik sherburne
25155 rye canyon loop
valencia, CA 91355
7632920920
MDR Report Key15584157
MDR Text Key301544908
Report Number3006630150-2022-05468
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729861638
UDI-Public08714729861638
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date10/22/2021
Device Model NumberSC-2317-70
Device Catalogue NumberSC-2317-70
Device Lot Number5180632
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/23/2019
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;
-
-