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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 Problems Pain (1994); Fluid Discharge (2686)
Event Date 01/17/2021
Event Type  Injury  
Manufacturer Narrative
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.During the processing of this complain, attempts to obtain patient information were attempted, but not received.
 
Event Description
Related manufacturer report number: 3006705815-2021-00521, 1627487-2021-01100, 1627487-2021-01101, 1627487-2021-01102.It was reported the patient presented to the emergency room on (b)(6) 2021 due to drainage at the ipg site.The patient was then given antibiotics and sent home, but the drainage continued.It was noted that the there was a small area on the incision that did not close and would scab and heal.The patient then presented to the hospital on (b)(6) 2021 due to increased pain at the anchor and lead sites.As a result, the patient underwent surgical intervention during which the system was explanted.
 
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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
Manufacturer (Section G)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
Manufacturer Contact
ronnie shalev
6901 preston road
plano, TX 75024
9723098000
MDR Report Key11305463
MDR Text Key231106881
Report Number1627487-2021-01099
Device Sequence Number1
Product Code GZB
UDI-Device Identifier05414734400671
UDI-Public05414734400671
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Physician
Type of Report Initial
Report Date 02/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2017
Device Model Number1192
Device Catalogue Number1192
Device Lot Number5221741
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/09/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SCS IPG; SCS LEAD (X2); SCS LEAD ANCHOR
Patient Outcome(s) Other;
Patient Age38 YR
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