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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
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BOSTON SCIENTIFIC NEUROMODULATION INFINION CX; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-2317-70
Device Problems Fracture (1260); High impedance (1291); Unexpected Therapeutic Results (1631)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2020
Event Type  malfunction  
Manufacturer Narrative
Exact date unknown, event occurred between (b)(6) 2020.
 
Event Description
It was reported that during a routine reprogramming session, a high impedance contact was discovered on the lead.The patient was unable to feel stimulation from the high impedance contact, thus stimulation was ineffective.The physician suspected that the lead fractured sometime between (b)(6) 2020.The patient's lead will be explanted and replaced.
 
Manufacturer Narrative
Block d6: update to implant date.
 
Event Description
It was reported that during a routine reprogramming session, a high impedance contact was discovered on the lead.The patient was unable to feel stimulation from the high impedance contact, thus stimulation was ineffective.The physician suspected that the lead fractured sometime between september and december 2020.The patient's lead will be explanted and replaced.
 
Manufacturer Narrative
The returned lead was analyzed and the complaint was confirmed.Visual and x ray inspection revealed that multiple cables were completely broken at the bent/kinked location of the lead.The bent/kinked location is 2cm from the set screw mark of the clik x anchor.No exposed cables were found at the fractured location.The lead was exposed to excessive mechanical force or movement which caused the cable fractures at the anchor point.Additionally, the lead was found to be cleanly cut near the distal array portion of the lead.The clean cut is a result of the typical explant procedure and is not considered a failure.With the available information, boston scientific concludes that inadequate stimulation and high impedances were caused by a lead fracture identified during laboratory analysis where the lead body exited the clik x anchor.The root cause of the reported clinical observation was traced to component failure.
 
Event Description
It was reported that during a routine reprogramming session, a high impedance contact was discovered on the lead.The patient was unable to feel stimulation from the high impedance contact, thus stimulation was ineffective.The physician suspected that the lead fractured sometime between (b)(4) 2020.The patient's lead will be explanted and replaced.Additional information was received that the patient's lead was explanted.The physician noted that there was a strong adhesion with the lead, the physician cut the lead so that it could be removed from the patient.
 
Manufacturer Narrative
Block b5: update to event description.Block d7: update to explant date.Block h6: update to impact code.
 
Event Description
It was reported that during a routine reprogramming session, a high impedance contact was discovered on the lead.The patient was unable to feel stimulation from the high impedance contact, thus stimulation was ineffective.The physician suspected that the lead fractured sometime between (b)(6) 2020.The patient's lead will be explanted and replaced.Additional information was received that the patient's lead was explanted.The physician noted that there was a strong adhesion with the lead, the physician cut the lead so that it could be removed from the patient.
 
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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
MDR Report Key11065806
MDR Text Key223587700
Report Number3006630150-2020-06366
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729861638
UDI-Public08714729861638
Combination Product (y/n)N
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 06/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/28/2020
Device Model NumberSC-2317-70
Device Catalogue NumberSC-2317-70
Device Lot Number5032148
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2021
Date Manufacturer Received06/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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