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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 No Known Impact Or Consequence To Patient (2692)
Event Date 05/31/2018
Event Type  Injury  
Manufacturer Narrative
The capa was initiated on 2016-02-23 to address the issue of the proclaim ipg entering service application. Investigation is complete and being monitored by the manufacturer. 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 patient underwent a pocket site revision on (b)(6) 2018 wherein monopolar electrocautery was utilized (please see mfr. Report#: 1627487-2018-06056). Prior to the procedure, the ipg was placed into surgery mode. During the procedure, an error message stated ¿there is a problem with the generator that could not be repaired¿ was displayed and the ipg would not communicate with external devices. As such, the physician explanted and replaced the patient¿s ipg, and therapy was confirmed.
 
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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 Key7641150
MDR Text Key112434080
Report Number1627487-2018-05600
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
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/01/2019
Device Model Number3660
Device Lot Number6185146
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number1627487/06/02/2017/001-C

Patient Treatment Data
Date Received: 06/27/2018 Patient Sequence Number: 1
Treatment
MODEL 1192 (2), SCS ANCHOR; MODEL 3186 (X2), SCS LEAD
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