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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 Abscess (1690)
Event Date 11/07/2017
Event Type  Injury  
Manufacturer Narrative
In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.
 
Event Description
Device 3 of 4.Reference mfr.Report#: 3006705815-2017-07189, reference mfr.Report#: 3006705815-2017-07190, reference mfr.Report#: 1627487-2017-07858.It was reported an abscess was found near the patient's lead site.No cultures have been taken and no antibiotics have been administered.The patient will undergo surgical intervention to address the issue.
 
Event Description
Device 3 of 4, reference mfr.Report#: 3006705815-2017-07189.Reference mfr.Report#: 3006705815-2017-07190.Reference mfr.Report#: 1627487-2017-07858.Follow-up revealed the patient's issue remains ongoing.In turn, the doctor re-packed the patient's incision(s) and prescribed bactrim ds to the patient.
 
Event Description
Device 3 of 4, reference mfr.Report#: 3006705815-2017-07189.Reference mfr.Report#: 3006705815-2017-07190.Reference mfr.Report#: 1627487-2017-07858.Follow-up revealed the patient's scs system was explanted.
 
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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
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key7069532
MDR Text Key93281307
Report Number1627487-2017-07857
Device Sequence Number1
Product Code GZB
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,health
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 02/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/22/2019
Device Model Number1192
Device Lot Number6098158
Other Device ID Number05415067024084
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/22/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age69 YR
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