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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Unspecified Infection (1930); Paralysis (1997)
Event Date 03/31/2021
Event Type  Injury  
Event Description
It was reported that the patient experienced paralysis at the lower extremities and was taken to the emergency room (er) for evaluation approximately two months after implantation.The patient had an infection around the leads due to an epidural abscess.The devices were explanted.No additional follow up is available at this time.
 
Manufacturer Narrative
Correction to block h10: additional suspect medical device component added.Additional suspect medical device component involved in the event: product family: scs-linear leads.Upn: m365sc2218500.Model: sc-2218-50.Serial: (b)(6).Batch: 7079732.
 
Event Description
It was reported that the patient experienced paralysis at the lower extremities and was taken to the emergency room (er) for evaluation approximately two months after implantation.The patient had an infection around the leads due to an epidural abscess.The devices were explanted.No additional follow up is available at this time.
 
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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
MDR Report Key11748264
MDR Text Key248046676
Report Number3006630150-2021-01846
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729767725
UDI-Public08714729767725
Combination Product (y/n)N
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date07/22/2022
Device Model NumberSC-2218-50
Device Catalogue NumberSC-2218-50
Device Lot Number7079589
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2021
Date Manufacturer Received08/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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