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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, DUAL 4 CHANNEL 10CM; SCS EXTENSION
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ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, DUAL 4 CHANNEL 10CM; SCS EXTENSION Back to Search Results
Model Number 3341
Device Problem Disconnection (1171)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/24/2020
Event Type  Injury  
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 Description
Related manufacturer reference number: 1627487-2020-31196 and 3006705815-2020-31301.During the elective ipg replacement the leads extension were inserted in the header and in post -op the impedance was high so patient was taken back into the or were it was discovered that the one of the extension pull out of the ipg header the extension was reinserted resolving the issue.
 
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
EXTENSION, DUAL 4 CHANNEL 10CM
Type of Device
SCS EXTENSION
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key10515374
MDR Text Key206348585
Report Number1627487-2020-31197
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05414734402279
UDI-Public05414734402279
Combination Product (y/n)N
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 11/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/28/2015
Device Model Number3341
Device Catalogue Number3341
Device Lot Number4093103
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SCS EXTENSION; SCS IPG; SCS EXTENSION; SCS IPG
Patient Outcome(s) Other;
Patient Weight76
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