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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION AVISTA MRI; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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BOSTON SCIENTIFIC NEUROMODULATION AVISTA MRI; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-2408-56
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
Patient Problems Scar Tissue (2060); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/12/2021
Event Type  Injury  
Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.
 
Event Description
It was reported that the patient underwent a lead revision procedure, in which the existing lead was explanted and a new lead was implanted.It was indicated that the reason for the lead revision procedure was due to the original lead not being implanted correctly due to anatomical difficulties, and no device problems were noted.The explanted lead was discarded by the facility and will no be returned for analysis.The patient is doing well post operatively.
 
Event Description
It was reported that the patient underwent a lead revision procedure, in which the existing lead was explanted and a new lead was implanted.It was indicated that the reason for the lead revision procedure was due to the original lead not being implanted correctly due to anatomical difficulties, and no device problems were noted.The explanted lead was discarded by the facility and will no be returned for analysis.The patient is doing well post operatively.Additional information was received that the lead and contacts were found to be lying intradurally and that both the lead and the clik anchor were removed and replaced with a new device.
 
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Brand Name
AVISTA MRI
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 Key11396880
MDR Text Key234180919
Report Number3006630150-2021-00692
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729904816
UDI-Public08714729904816
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,foreig
Type of Report Initial,Followup
Report Date 04/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date07/15/2022
Device Model NumberSC-2408-56
Device Catalogue NumberSC-2408-56
Device Lot Number7071420
Was Device Available for Evaluation? No
Date Manufacturer Received03/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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