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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL SWIFT-LOCK ANCHOR; SCS LEAD ANCHOR
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ABBOTT MEDICAL SWIFT-LOCK ANCHOR; SCS LEAD ANCHOR Back to Search Results
Model Number 1192
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 09/21/2021
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.During processing of this incident, attempts were made to obtain complete patient information.
 
Event Description
Related manufacturer reference number: 3006705815-2021-04952, 3006705815-2021-04953, 3006705815-2021-04954 , 1627487-2021-17509.It was reported that patient experienced infection at the both ipg and lead site.As a result, the entire scs system was explanted.
 
Manufacturer Narrative
A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event.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 LEAD ANCHOR
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key12595474
MDR Text Key275469434
Report Number1627487-2021-17508
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,consum
Type of Report Initial,Followup
Report Date 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/10/2023
Device Model Number1192
Device Catalogue Number1192
Device Lot Number7791293
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/08/2021
Patient Sequence Number1
Treatment
PERCUTANEOUS LEAD (2).; SCS IPG.; SCS LEAD ANCHOR.; PERCUTANEOUS LEAD (2); SCS IPG; SCS LEAD ANCHOR
Patient Outcome(s) Other;
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