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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 Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/04/2021
Event Type  Injury  
Event Description
Related manufacturer reference number: 1627487-2021-16526.It was reported that during a lead revision surgery (related manufacturer reference numbers 3006705815-2021-04131, 3006705815-2021-04132) on (b)(6) 2021, one of the anchors appeared to be broken.The physician explanted and replaced the anchor.It is unknown which anchor was replaced, therefore both anchors are being reported.
 
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
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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 Key12357270
MDR Text Key267817689
Report Number1627487-2021-16525
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,health
Type of Report Initial,Followup
Report Date 09/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/27/2022
Device Model Number1192
Device Catalogue Number1192
Device Lot Number7625628
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SCS ANCHOR; SCS ANCHOR
Patient Outcome(s) Other;
Patient Weight66
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