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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 Communication or Transmission Problem (2896)
Patient Problem Inadequate Pain Relief (2388)
Event Type  Injury  
Event Description
Additional information received identified the ipg was explanted and replaced with another model which resolved the issue.
 
Manufacturer Narrative
Concomitant product(s): the therapy date for the following device is unknown: model: 3228; scs lead. 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 (b)(6) the patient's ipg would no longer connect with the patient or clinician programmer. The patient reportedly underwent a few surgeries since the implantation of the ipg. The patient does not have stimulation currently. Surgical intervention is planned to address the issue. The manufacturer has requested additional details on the device.
 
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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
MDR Report Key7153328
MDR Text Key107264972
Report Number1627487-2017-08800
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/23/2018
Device Model Number3660
Device Lot Number5423327
Other Device ID Number05415067020192
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/23/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number1627487-060217-001-C

Patient Treatment Data
Date Received: 12/28/2017 Patient Sequence Number: 1
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