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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROCLAIM 5 ELITE SCS IPG

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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROCLAIM 5 ELITE SCS IPG Back to Search Results
Model Number 3789
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Seroma (2069); Post Operative Wound Infection (2446); Fluid Discharge (2686)
Event Date 07/04/2019
Event Type  Injury  
Manufacturer Narrative
During processing of this complaint, attempts were made to obtain patient's weight, but the information was not received. The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
It was reported that patient has infection as the ipg site and the patient went to the emergency room where an abscess was found at l2-l3. A seroma was later confirmed via x-rays. Patient is being treated with oral antibiotics.
 
Event Description
Related manufacturer reference number: 1627487-2019-08497, 3006705815-2019-02810. Additional information received indicated that the physician did not report any signs of infection. A fluid discharge was noticed at the ipg pocket site and drained in the physician¿s office. The issue was resolved.
 
Manufacturer Narrative
The device history record was reviewed to ensure proper packaging and sterility. Based on the information received, the cause of the reported incident could not be conclusively determined.
 
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Brand NamePROCLAIM 5 ELITE
Type of DeviceSCS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
lot a interior - #2 street km 67.5
santana industrial park
arecibo PR 00612
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
lot a interior - #2 street km 67.5
santana industrial park
arecibo PR 00612
Manufacturer Contact
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key8804537
MDR Text Key151499356
Report Number3006705815-2019-02701
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,consum
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/23/2021
Device Model Number3789
Device Lot NumberA000080727
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 Received09/03/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/24/2019
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: 07/18/2019 Patient Sequence Number: 1
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