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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION SWIFT-LOCK ANCHOR; SCS - ANCHOR
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ST. JUDE MEDICAL - NEUROMODULATION SWIFT-LOCK ANCHOR; SCS - ANCHOR Back to Search Results
Model Number 1192
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 01/01/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event or Problem Description
Related manufacturer reference number: 3006705815-2019-03820, 1627487-2019-11285, 1627487-2019-11286.It was reported that the patient experienced an infection.As a result, the patient's system was explanted in (b)(6) 2018 (exact date of explant is unknown).
 
Additional 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
Common Device Name
SCS - ANCHOR
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key9158150
Report Number1627487-2019-11284
Device Sequence Number2449253
Product Code GZB
UDI-Device Identifier05415067016621
UDI-Public05415067016621
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K092371
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Reporter Type Manufacturer
Report Source company representative,consum
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 10/17/2019
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? No
Operator of Device Health Professional
Device Expiration Date03/31/2017
Device Model Number1192
Device Lot Number5062580
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 10/02/2019
Supplement Date Received by Manufacturer10/15/2019
Initial Report FDA Received Date10/04/2019
Supplement Report FDA Received Date10/17/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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