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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION SCS EXTENSTION

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ST. JUDE MEDICAL - NEUROMODULATION SCS EXTENSTION Back to Search Results
Device Problems High impedance (1291); Difficult to Insert (1316)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/18/2019
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided on the final report. Further information was requested but not received.
 
Event Description
Related manufacturer reference number: 1627487-2019-07818 & 1627487-2019-07820. It was reported that the patient experienced invalid impedances. As a result, surgical intervention was taken. During the procedure, it was noted that the extension was not fully inserted into the ipg header. The physician experienced difficulty fully inserting the extension into the header. The physician elected to leave the extension as is. An additional procedure is pending.
 
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.
 
Event Description
Related manufacturer reference number: 1627487-2019-07818 & 1627487-2019-07820. Surgical intervention was taken on (b)(6) 2019 to replace the ipg. During the revision it was noted that the extension was broken. As a result, the extensions were both replaced. Issue has been resolved.
 
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Type of DeviceSCS EXTENSTION
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
Manufacturer Contact
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key8771558
MDR Text Key150406292
Report Number1627487-2019-07819
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/09/2019 Patient Sequence Number: 1
Treatment
SCS EXTENSTION; SCS IPG
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