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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-2317-50
Device Problems Unexpected Therapeutic Results (1631); Migration (4003)
Patient Problem Inadequate Pain Relief (2388)
Event Date 10/12/2022
Event Type  Injury  
Manufacturer Narrative
Date approximate.
 
Event Description
It was reported that the patient experienced inadequate stimulation coverage due to lead migration.The spinal cord stimulator system was reprogrammed however the patients pain area could not be covered.The patient underwent a lead replacement procedure.The patient was doing fine post-operatively.
 
Manufacturer Narrative
Sc-2317-50, serial (b)(6): the returned lead was analyzed and revealed that all cables were completely broken at the bent-kinked location of the lead.The bent-kinked location is near the set screw mark of the clik x anchor.There are no exposed cables at the fracture location.The lead was kinked after it exits the clik x anchor resulting in the reported complaint.It appears that the lead was exposed to excessive mechanical force or movement causing the cable fractures right at the anchor point.Additionally, lead migration resulting in inadequate stimulation can also occur and are known inherent risks associated with use of the device.
 
Event Description
It was reported that the patient experienced inadequate stimulation coverage due to lead migration.The spinal cord stimulator system was reprogrammed however the patients pain area could not be covered.The patient underwent a lead replacement procedure.The patient was doing fine post-operatively.
 
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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
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 Key15720245
MDR Text Key302935150
Report Number3006630150-2022-05945
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729861614
UDI-Public08714729861614
Combination Product (y/n)N
Reporter Country CodeUK
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 02/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date08/23/2023
Device Model NumberSC-2317-50
Device Catalogue NumberSC-2317-50
Device Lot Number7075229
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/23/2021
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;
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