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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 7 ELITE SCS IPG

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ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 7 ELITE SCS IPG Back to Search Results
Model Number 3662
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446); Fluid Discharge (2686)
Event Date 08/21/2018
Event Type  Injury  
Manufacturer Narrative
In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing. 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 developed a superficial infection at the ipg incision site several weeks ago. Reportedly, the wound scabbed and showed signs of incomplete healing. Reportedly, the physician opted to open the ipg incision site on (b)(6) 2018 during which the affected tissue was removed and the site re-closed. Cultures were obtained with negative results. During the (b)(6) 2018 postoperative visit, the patient was immediately taken into surgery wherein the entire scs was explanted due to the wound was open and draining fluid.
 
Event Description
Additional follow-up identified the patient has a medical history of diabetes. Reportedly, culture results returned negative and the issue has since been resolved.
 
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Brand NamePROCLAIM 7 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
melissa nkematu
6901 preston road
plano, TX 75024
9723092520
MDR Report Key7926348
MDR Text Key122342662
Report Number1627487-2018-09408
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,Followup
Report Date 10/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/30/2020
Device Model Number3662
Device Lot Number6477992
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 Received09/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2018
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: 10/02/2018 Patient Sequence Number: 1
Treatment
MODEL 1192 (2), SCS ANCHOR; MODEL 3186 (2), SCS LEAD
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