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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); Appropriate Term/Code Not Available (3191); Migration (4003)
Patient Problem No Code Available (3191)
Event Date 02/14/2019
Event Type  malfunction  
Manufacturer Narrative
Additional medical suspect device components involved: reference number: (b)(4), product family: scs-linear leads, upn: (b)(4), model: sc-2317-70, serial: (b)(4), batch: (b)(4).
 
Event Description
A report was received that high impedances were measured on the patient's leads.The high impedances were noted on contacts 2-3 and 10-11.The patient underwent a lead revision procedure where the lead was explanted.The lead was loose from the ipg header.The lead was noted to be very weak and bent about 4cm away from the 1st contact of the bsn splitter.The lead seems to have been broken.
 
Event Description
A report was received that high impedances were measured on the patient's leads.The high impedances were noted on contacts 2-3 and 10-11.The patient underwent a lead revision procedure where the lead was explanted.The lead was loose from the ipg header.The lead was noted to be very weak and bent about 4cm away from the 1st contact of the bsn splitter.The lead seems to have been broken.
 
Manufacturer Narrative
Additional information was received that lead serial number (b)(4) was not explanted from the patient.The complaint high impedances were confirmed.Visual (microscope) and x-ray inspection of the lead revealed that all cables were completely broken at the bent/kinked location of the lead.The bent/kinked location is 2 cm from the set screw mark of the clik x anchor.There are no exposed cables at the clik x anchor site fracture locations.The reported complaints of high impedances were caused by the fractured cables at the clik x anchor site.Additionally, the distal end of lead was cut and not returned.The cut damage to the lead is consistent with damages done during the explant procedure and are not considered a failure.
 
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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 Key8529648
MDR Text Key142469452
Report Number3006630150-2019-01767
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
Report Date 04/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date06/28/2020
Device Model NumberSC-2317-70
Device Catalogue NumberSC-2317-70
Device Lot Number5071185
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2019
Date Manufacturer Received04/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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