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

Model Number 3660

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burning Sensation (2146); Implant Pain (4561)

Event Date 03/09/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced pain at the ipg site.As such, surgical intervention took place wherein the ipg was explanted addressing the issue.Reportedly, the issue was resolved.

Manufacturer Narrative

The report of pain at the ipg site was not able to be confirmed.Analysis of the returned ipg found it communicated with all lab utilities and passed all functional testing (no anomalous outputs were observed).Discomfort or pain at the ipg site is commonly associated with patient anatomy and/or the location of the ipg pocket site.The report did not state if the location of the pocket site was an issue for the patient.The report stated that the entire system was explanted due to ineffective therapy (related manufacturer number: 3006705815-2022-15522 and 3006705815-2022-15523).

Event Description

Additional information received indicates that the ipg gets warm and causes a shock.Reportedly, the patient experienced shocking sensation and burn at the ipg site.

• 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
• 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 15341604
• MDR Text Key: 299137467
• Report Number: 3006705815-2022-16545
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067031419
• UDI-Public: 05415067031419
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2023
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: A000114364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2021
• 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
• Treatment: SCS ANCHOR (X2).; SCS LEAD (X2).
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 59 KG