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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 5 ELITE SCS IPG

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ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 5 ELITE SCS IPG Back to Search Results
Model Number 3660
Device Problem Device Inoperable (1663)
Patient Problem Inadequate Pain Relief (2388)
Event Date 05/29/2018
Event Type  Injury  
Manufacturer Narrative
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
It was reported the ipg was inoperable. As a result, the ipg was replaced. Effective therapy was restored post-op.
 
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Brand NamePROCLAIM 5 ELITE
Type of DeviceSCS IPG
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
jason baker
6901 preston road
plano, TX 75024
9725268292
MDR Report Key7638438
MDR Text Key112352006
Report Number1627487-2018-06052
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2018
Device Model Number3660
Device Lot Number5752247
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 Received05/29/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2016
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: 06/26/2018 Patient Sequence Number: 1
Treatment
MODEL 3228, SCS LEAD
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