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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 Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Therapeutic Results (1631); Migration (4003)
Patient Problems Undesired Nerve Stimulation (1980); Inadequate Pain Relief (2388)
Event Date 01/10/2022
Event Type  Injury  
Event Description
It was reported the patient experienced over-stimulation in the non-target pain area of the front ribs causing cramping. Additionally, the patient experienced inadequate stimulation in the targeted pain area of the mid-thoracic back. X-ray imaging taken in the field confirmed the leads had migrated. Reprogramming attempts were unsuccessful and the patient underwent a procedure where the spinal cord stimulation (scs) system was removed. The explanted leads were not returned for analysis as they were discarded by the facility.
 
Manufacturer Narrative
Date of event: approximated based on the date the manufacturer became aware of the event. Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2317700, model: sc-2317-70, serial: (b)(4), batch: 5098768.
 
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Brand NameINFINION CX
Type of DeviceSTIMULATOR, 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
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key15192895
MDR Text Key297533549
Report Number3006630150-2022-03929
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
Type of Report Initial
Report Date 08/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/09/2022
Device Model NumberSC-2317-70
Device Catalogue NumberSC-2317-70
Device Lot Number3159870
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/11/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/09/2022 Patient Sequence Number: 1
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