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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-2218-50
Device Problem Migration (4003)
Patient Problems Discomfort (2330); Obstruction/Occlusion (2422)
Event Date 06/03/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: exact date unknown, event occurred in (b)(6) 2021. Additional suspect medical device component involved in the event: product family: scs-linear lead, upn: m365sc2218500, model: sc-2218-50, serial: (b)(4), batch: 5162770.
 
Event Description
It was reported that the patient was having discomfort on the left side of the back, torso and ribs and was feeling pressure on the rectum with difficulty passing a bowel movement post lead revision procedure (mfr. Report number: 3006630150-2021-03124). The x ray revealed that the left lead had migrated cadually. The patient underwent an explant procedure wherein only the left lead was removed. The patient was doing well postoperatively and explanted lead will not be returned.
 
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Brand NameLINEAR ST
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 Key12530723
MDR Text Key273315262
Report Number3006630150-2021-05395
Device Sequence Number1
Product Code LGW
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSC-2218-50
Device Catalogue NumberSC-2218-50
Device Lot Number7091913
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/16/2021
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: 09/25/2021 Patient Sequence Number: 1
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