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 16; 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 16; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-2316-50E
Device Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2023
Event Type  malfunction  
Event Description
It was reported that during the trial lead removal, one lead appeared to have some resistance in coming out of the patient.The physician applied additional force in removing the lead after which the distal end was visibly broken and showed four contacts that were missing.The missing contacts were left inside the patients body which was confirmed through imaging.The patient status was good.
 
Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-linear leads.Upn: m365sc231650e0.Model: sc-2316-50e.Serial: (b)(6).Batch: 7196395.
 
Event Description
It was reported that during the trial lead removal, one lead appeared to have some resistance in coming out of the patient.The physician applied additional force in removing the lead after which the distal end was visibly broken and showed four contacts that were missing.The missing contacts were left inside the patients body which was confirmed through imaging.The patient status was good.
 
Manufacturer Narrative
(b)(4) (sn: (b)(6)).The returned lead was analyzed, and the complaint of lead damage was confirmed.Visual inspection revealed that the top seven electrodes are separated from the distal end.Electrodes 1-4 were not returned.It appears 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, and several cables are exposed.Visual inspection of the fractured cables revealed fraying of the breaks, lack of necking and discoloration associated with welding, and the proximity of the break points to the edge of the insulation indicate that the cables didn't break at or near the welds.It appears that resistance was felt during the lead pull and lead was subjected to excessive tensile load causing damage to the distal array.This is a result of a typical explant procedure and is not considered a failure.The probable cause is unintended use error caused or contributed to event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INFINION 16
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 Key16826974
MDR Text Key314128524
Report Number3006630150-2023-02331
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729797807
UDI-Public08714729797807
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberSC-2316-50E
Device Catalogue NumberSC-2316-50E
Device Lot Number7195417
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/06/2023
Initial Date FDA Received04/27/2023
Supplement Dates Manufacturer Received05/15/2023
Supplement Dates FDA Received06/01/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/14/2023
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 Age73 YR
Patient SexMale
-
-