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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 Problems Device Inoperable (1663); Communication or Transmission Problem (2896)
Patient Problems Fall (1848); Inadequate Pain Relief (2388)
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 after suffering a fall onto the ipg site, the patient lost stimulation and the ipg would no longer communicate with external devices. As a result, the physician explanted and replaced the ipg. Postoperatively, effective therapy was restored.

 
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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
joanne story
9725264875
MDR Report Key7658053
MDR Text Key113002846
Report Number1627487-2018-05844
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/20/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/03/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/25/2019
Device MODEL Number3660
Device LOT Number6070166
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/09/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/30/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/25/2017
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: 07/03/2018 Patient Sequence Number: 1
Treatment
MODEL 3228, SCS LEAD
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