MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 5 ELITE; SCS IPG

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.

• Brand Name: PROCLAIM 5 ELITE
• Type of Device: SCS 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 Key: 9409307
• MDR Text Key: 169013759
• Report Number: 1627487-2019-13505
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020192
• UDI-Public: 05415067020192
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• 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 Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2019
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: 5940469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 66