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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.The unique device identifier (udi #) is unknown because the lot and part number were not provided.
 
Event Description
Related manufacturer report number: 3006705815-2020-02912.It was reported the cervical ipg and thoracic anchor were superficial and causing patient discomfort.In turn, surgical intervention may take place later to address the issue.
 
Event Description
Additional information indicated that a surgical intervention occured wherein the anchor was repositioned and therapy was restored.
 
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)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key10310911
MDR Text Key199982745
Report Number1627487-2020-23055
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,consum
Type of Report Initial,Followup,Followup
Report Date 09/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number1192
Device Catalogue Number1192
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SCS IPG
Patient Outcome(s) Other;
Patient Weight54
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