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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL SWIFT-LOCK ANCHOR; SCS ANCHOR
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ABBOTT MEDICAL SWIFT-LOCK ANCHOR; SCS ANCHOR Back to Search Results
Model Number 1192
Device Problem Installation-Related Problem (2965)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/13/2020
Event Type  Injury  
Manufacturer Narrative
The results, method, and conclusion codes along with the investigation results will be provided in final report.
 
Event Description
Related manufacturer reference number: 3006705815-2020-32886.It was reported that during an elective ipg procedure the patients lead migrated out of the epidural space.Upon inspection it was found that the lead anchor had opened resulting in the migration.During the procedure the lead and anchor were explanted and replaced.
 
Manufacturer Narrative
The reported event of functional issue of the anchor was not confirmed.As received, the anchor was post capa 140614 and complete, and worked as design.No root cause was identified for the reported event.
 
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Brand Name
SWIFT-LOCK ANCHOR
Type of Device
SCS ANCHOR
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key10904927
MDR Text Key218634744
Report Number1627487-2020-48124
Device Sequence Number1
Product Code GZB
UDI-Device Identifier05415067024084
UDI-Public05415067024084
Combination Product (y/n)N
PMA/PMN Number
K092371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/10/2021
Device Model Number1192
Device Catalogue Number1192
Device Lot Number6881576
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2020
Was the Report Sent to FDA? No
Date Manufacturer Received01/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MODEL: 3186, SCS LEAD
Patient Outcome(s) Other;
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