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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION LINEAR ST; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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BOSTON SCIENTIFIC NEUROMODULATION LINEAR ST; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-2218-70
Device Problems High impedance (1291); Unexpected Therapeutic Results (1631)
Patient Problem Inadequate Pain Relief (2388)
Event Date 01/20/2021
Event Type  Injury  
Event Description
It was reported that the patient experienced inadequate stimulation due to high impedances.It was attempted to cover the pain area by reprogramming around the high impedances, but reprogramming was not successful.The patient underwent a revision procedure in which the lead was replaced.The patient is doing well post operatively.
 
Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.
 
Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.The returned lead was analyzed and visual (microscope) and x-ray inspection of the lead revealed that multiple cables were completely broken at the bent/kinked location of the lead.The bent/kinked location is 1 cm from the set screw mark of the clik anchor.There are no exposed cables at the fracture location.The lead got kinked after it exits the clik anchor resulting in the reported complaint.A labeling review was performed on the lead instructions for use, ifu.There was no evidence that the device was used in a manner inconsistent with the labeled indications.Based on all available information, engineers were able to confirm the root cause of the inadequate stimulation due to the high impedances on the lead.The production record review, database analysis, and device technical analysis revealed no product issues.However device analysis of the lead confirmed the root cause as traced to component failure.
 
Event Description
It was reported that the patient experienced inadequate stimulation due to high impedances.It was attempted to cover the pain area by reprogramming around the high impedances, but reprogramming was not successful.The patient underwent a revision procedure in which the lead was replaced.The patient is doing well post operatively.
 
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Brand Name
LINEAR ST
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
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key12925176
MDR Text Key282006370
Report Number3006630150-2021-06900
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729767749
UDI-Public08714729767749
Combination Product (y/n)N
Reporter Country CodeCA
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 02/18/2022
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 Lay User/Patient
Device Expiration Date01/11/2021
Device Model NumberSC-2218-70
Device Catalogue NumberSC-2218-70
Device Lot Number5116696
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/12/2019
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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