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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SWIFT-LOCK ANCHOR; SCS ANCHOR
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SWIFT-LOCK ANCHOR; SCS ANCHOR Back to Search Results
Model Number 1192
Device Problem Migration (4003)
Patient Problem Implant Pain (4561)
Event Date 09/23/2021
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.
 
Event Description
It was reported that the patient experienced pain at the anchor site.The suture had come undone and the anchor was pushed up.As a result, surgical intervention was undertaken on (b)(6) 2021 wherein the lead was re-sutured, resolving the issue.
 
Manufacturer Narrative
A4 patient weight added to the record.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
 
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Brand Name
SWIFT-LOCK ANCHOR
Type of Device
SCS ANCHOR
MDR Report Key12637851
MDR Text Key276569016
Report Number1627487-2021-17739
Device Sequence Number1
Product Code GZB
UDI-Device Identifier05414734400671
UDI-Public05414734400671
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,consum
Type of Report Initial,Followup
Report Date 11/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/17/2023
Device Model Number1192
Device Catalogue Number1192
Device Lot Number7969016
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/17/2021
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) Other;
Patient Weight84
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