Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL SWIFT-LOCK ANCHOR; SCS ANCHOR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT MEDICAL SWIFT-LOCK ANCHOR; SCS ANCHOR Back to Search Results
Model Number 1192
Device Problem Fracture (1260)
Patient Problem Inadequate Pain Relief (2388)
Event Date 05/01/2020
Event Type  Injury  
Manufacturer Narrative
The results/ method and conclusion codes along with investigation results will be provided when the evaluation is completed.
 
Event Description
Related mfr reports: 1627487-2020-32378, 1627487-2020-32379 and 1627487-2020-32381.It was reported surgical intervention was taken to replace the patient's fractured scs system leads.Reportedly, during the procedure the lead anchors were found broken in half.Both leads and anchors were replaced and the reported issue addressed.No patient adverse consequences were reported.
 
Manufacturer Narrative
The results of the investigation are inconclusive since the devices were not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.
 
Event Description
Related mfr reports: 1627487-2020-32378, 1627487-2020-32379 and 1627487-2020-323810.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SWIFT-LOCK ANCHOR
Type of Device
SCS ANCHOR
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key10653153
MDR Text Key210595087
Report Number1627487-2020-32380
Device Sequence Number1
Product Code GZB
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 11/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1192
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/18/2020
Initial Date FDA Received10/08/2020
Supplement Dates Manufacturer Received11/24/2020
Supplement Dates FDA Received11/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MODEL 1192, SCS ANCHOR; MODEL 3186 (X2), SCS LEAD
Patient Outcome(s) Other;
Patient Age41 YR
Patient Weight70
-
-