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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL SWIFT-LOCK ANCHOR
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ABBOTT MEDICAL SWIFT-LOCK ANCHOR Back to Search Results
Model Number 1192
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Post Operative Wound Infection (2446)
Event Date 12/03/2020
Event Type  Injury  
Manufacturer Narrative
The results/ method and conclusion codes along with investigation results will be provided in the final report.Date of event and concomitant medical products therapy dates are estimated.
 
Event Description
Related manufacturer reference numbers: 3006705815-2020-33466, 3006705815-2020-33467 and 1627487-2020-49280.It was reported the anchors had eroded and an infection was present at the anchor and leads.Devices were explanted.
 
Event Description
Related manufacturer reference number: 3006705815-2020-33466, 3006705815-2020-33467 and 1627487-2020-49280.Additional information received revealed the infection was treated with antibiotics to provide resolution.
 
Manufacturer Narrative
The reported issue for infection cannot be confirmed through product analysis testing.As received, the swift lock anchor showed no anomaly and worked as design.No root cause was identified for reported event.
 
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Brand Name
SWIFT-LOCK ANCHOR
Type of Device
SWIFT-LOCK ANCHOR
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key11085427
MDR Text Key224037316
Report Number1627487-2020-49281
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 02/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/26/2022
Device Model Number1192
Device Catalogue Number1192
Device Lot Number7400059
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2020
Was the Report Sent to FDA? No
Date Manufacturer Received01/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MODEL OCTRODE LEAD KIT, 60CM LENGTH; MODEL OCTRODE LEAD KIT, 60CM LENGTH; MODEL SWIFT-LOCK ANCHOR; MODEL OCTRODE LEAD KIT, 60CM LENGTH; MODEL OCTRODE LEAD KIT, 60CM LENGTH; MODEL SWIFT-LOCK ANCHOR
Patient Outcome(s) Other;
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