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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 Adverse Event Without Identified Device or Use Problem (2993); Temperature Problem (3022)
Patient Problems Edema (1820); Pain (1994); Burning Sensation (2146)
Event Date 11/01/2019
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated. The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
It was reported the patient was experiencing pain and swelling at the ipg site. As a result, surgical intervention was undertaken on (b)(6) 2019 wherein the ipg was explanted and replaced. Issue resolved.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the patient was experiencing pain, swelling, and a burning sensation at the ipg site. As a result, surgical intervention was undertaken on (b)(6) 2019 wherein the ipg was explanted and replaced. Issue resolved.
 
Manufacturer Narrative
(b)(4). The reported pain and swelling at the ipg site was not confirmed. This issue cannot be confirmed with product testing alone. The reported pocket heating issue was not confirmed. The ipg was returned without any visible anomalies that would contribute to the reported issue. Using the clinician¿s programmer, normal pairing and bluetooth (ble) communication was observed. The field scenario was recreated by attaching the ipg to a load block and placing in a heated chamber and allowing the temperature to stabilize. After 4 hours, the temperature of the ipg increased by only 0. 2c degrees. This rise in temperature met the specification for heat generation during use. The returned ipg was subjected to a functional test on automated test equipment (ate). This tester verifies the electrical performance of the control/communication circuitry, and output signal integrity. All portions of ate testing passed. The root cause of the reported issues could not be determined.
 
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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
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key9409307
MDR Text Key169013759
Report Number1627487-2019-13505
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 03/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/12/2019
Device Model Number3660
Device Catalogue Number3660
Device Lot Number5940469
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/12/2017
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: 12/04/2019 Patient Sequence Number: 1
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