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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 High impedance (1291); Unexpected Therapeutic Results (1631)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/26/2022
Event Type  Injury  
Manufacturer Narrative
Event date: approximated based on the date the manufacturer became aware of the event. Additional suspect medical device component involved in the event: product family: scs-linear leads; upn: m365sc2317500; model: sc-2317-50; serial: (b)(4); batch: 7074990.
 
Event Description
It was reported that the patient experienced loss of stimulation due to high impedances on the leads. The patient underwent a lead replacement procedure and was doing well post-operatively. The explanted leads will not be returned as they were discarded by the medical facility.
 
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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 Key15229991
MDR Text Key297945292
Report Number3006630150-2022-04063
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729861614
UDI-Public08714729861614
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSC-2317-50
Device Catalogue NumberSC-2317-50
Device Lot Number7074944
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/21/2021
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: 08/15/2022 Patient Sequence Number: 1
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