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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 05/21/2018
Event Type  Injury  
Manufacturer Narrative

The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 2017. 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

The patient has 2 scs systems: theoretic and cervical. The report is referencing the patient's theoretic system. It was reported following an explant of the patient's cervical scs system on (b)(6) 2018,(reference mfr. Report#: 1627487-2018-05761 and 1627487-2018-05762), the clinician's programmer (cp) reflected the error message: "generator is not ready. Wait 30 seconds. " in addition, when attempting to connect with the ipg, the cp reflected the error message: "the system encountered a problem with the generator that could not be repaired. Please contact sjm. " it was noted the patient's ipg was placed in surgery mode prior to the procedure. The patient is without stimulation.

 
Event Description

Follow-up information revealed the patient underwent surgical intervention wherein the ipg was explanted and replaced. Effective therapy resumed postoperatively.

 
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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
jennifer shepard
plano, TX 75024
9725264657
MDR Report Key7600994
MDR Text Key111039419
Report Number1627487-2018-05439
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
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/24/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/14/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/22/2019
Device MODEL Number3660
Device LOT Number5911006
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/27/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/22/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction Number1627487/06/02/2017/001-C

Patient TREATMENT DATA
Date Received: 06/14/2018 Patient Sequence Number: 1
Treatment
MODEL 3228, SCS LEAD
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