MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 7 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG

Model Number 3662

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

Patient Problems Edema (1820); Fever (1858); Unspecified Infection (1930)

Event Date 01/14/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided on the final report.

Event Description

It was reported that infection was observed and as a result patient experienced edema and fever.As a result a full system was explanted.There were no complications during the procedure.Patient was stable.

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.

Manufacturer Narrative

The reported issue for ¿infection¿ cannot be confirmed through product analysis testing.Production records pertinent to sterility and packaging were reviewed for the reported lot number, for the returned product and no nonconformance's were found.Analysis of the returned ipg found: as received, the ipg was inoperable, the inability to communicate between the clinicians programmer and the implantable pulse generator was due to the device entering the service application state.This issue can occur when the device is exposed to an external energy source outside the device handling and storage requirements.Once the device has entered into the service application state, the cp will be inhibited from programming the device into the therapy application state.Since there were no reports of an unrelated surgery prior to explant this exposure to an external energy source (electrocautery) occurred during the explant procedure.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.

• Brand Name: PROCLAIM 7 ELITE IMPLANTABLE PULSE GENERATOR
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 9702110
• MDR Text Key: 179136923
• Report Number: 1627487-2020-01481
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020222
• UDI-Public: 05415067020222
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2021
• Device Model Number: 3662
• Device Catalogue Number: 3662
• Device Lot Number: 6983295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other