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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 Unexpected Therapeutic Results (1631); Migration (4003)
Patient Problems Fall (1848); Inadequate Pain Relief (2388)
Event Date 08/10/2021
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-linear leads, upn: m365sc2317700, model: sc-2317-70, serial: (b)(4), batch: 7071236.
 
Event Description
It was reported that the patient was not receiving adequate pain relief approximately 2 months after a fall. Through x-ray imaging the physician assessed that the leads had migrated. The patient underwent a revision procedure to replace both leads. The patient was noted to be stable post operatively. The explanted leads were discarded by the hospital and were not returned.
 
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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 Key12928629
MDR Text Key281743605
Report Number3006630150-2021-06917
Device Sequence Number1
Product Code LGW
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 12/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/15/2021
Device Model NumberSC-2317-70
Device Catalogue NumberSC-2317-70
Device Lot Number5179566
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/16/2019
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: 12/03/2021 Patient Sequence Number: 1
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