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

Model Number 3660

Device Problem Unexpected Shutdown (4019)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

It was reported the patient experienced unexpected shutdown of stimulation with their ipg.Troubleshooting was unable to resolve the issue.In turn, surgical intervention may be pending to address the issue.

Event Description

Additional information received indicated the patient underwent surgical intervention wherein the ipg was explanted and replaced to address the issue.

Manufacturer Narrative

The reported observation of ¿therapy turning off unintentionally¿ was not confirmed or duplicated during analysis.The cause of the reported observation was not ascertained; the device exhibited normal device characteristics.The implantable pulse generator (ipg) diagnostic logs do show during the implant period stimulation was turned off and on repeatedly.It was also confirmed that once the device magnet mode was programmed to ¿ignore¿ while still implanted no further magnet events were logged, which is normal operation.The device 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.The ate test specifically tests the ipg output on all 16 electrodes including the ipg can.The magnet function of the ipg is tested during the ate test.All portions of ate testing passed.

• Brand Name: PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR
• Type of Device: SCS 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
• MDR Report Key: 11983786
• MDR Text Key: 255646157
• Report Number: 3006705815-2021-02917
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067031419
• UDI-Public: 05415067031419
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2022
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: A000097360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 57