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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 Migration (4003)
Patient Problems Pain (1994); Inadequate Pain Relief (2388); Swelling/ Edema (4577)
Event Date 01/29/2021
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.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.
 
Event Description
Related manufacturer reference numbers: 1627487-2021-01361, 1627487-2021-01362, 1627487-2021-01364.It was reported that patient experienced left shoulder pain and swelling after a fall.Imaging confirmed left lead and anchor migration.Surgical intervention may be pending to address the issue.It is unknown which lead and anchor migrated, so both leads and both anchors are being reported.
 
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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 Key11347130
MDR Text Key232506614
Report Number1627487-2021-01363
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 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/20/2020
Device Model Number1192
Device Catalogue Number1192
Device Lot Number6491038
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PERCUTANEOUS LEAD X2; SCS ANCHOR; PERCUTANEOUS LEAD X2; SCS ANCHOR
Patient Outcome(s) Other;
Patient Age49 YR
Patient Weight82
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