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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION 8-CHANNEL ADAPTER, MDT, 10CM; SCS EXTENSION
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ST. JUDE MEDICAL - NEUROMODULATION 8-CHANNEL ADAPTER, MDT, 10CM; SCS EXTENSION Back to Search Results
Model Number 2311
Device Problems Disconnection (1171); High impedance (1291)
Patient Problem Inadequate Pain Relief (2388)
Event Date 06/25/2020
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.Date of event is estimated.
 
Event Description
Related manufacturer reference number: 1627487-2020-22721, 3006705815-2020-02750.It was reported after an implant procedure the patient experienced ineffective stimulation due to high impedances.The patient underwent surgical intervention on (b)(6) 2020 where it was discovered one of the adapters was not connected and then reconnected to address the issue.Therapy was restored postoperatively.
 
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
8-CHANNEL ADAPTER, MDT, 10CM
Type of Device
SCS EXTENSION
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key10270026
MDR Text Key198686763
Report Number1627487-2020-22722
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05415067016119
UDI-Public05415067016119
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,health
Type of Report Initial,Followup
Report Date 07/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/21/2022
Device Model Number2311
Device Catalogue Number2311
Device Lot Number7352308
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/16/2020
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 Weight84
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