MAUDE Adverse Event Report: ABBOTT MEDICAL PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG

Model Number 3660

Device Problem Wireless Communication Problem (3283)

Patient Problem Failure of Implant (1924)

Event Date 09/08/2021

Event Type  Injury  

Event Description

It was reported that during a revision of leads, ipg was placed in surgery mode prior to the procedure.During the procedure company representative were unable to recover the connection.Troubleshooting was done during the procedure and exhausted all steps.As such a new ipg was opened and replaced with the old ipg, thereby addressing the issue.

Manufacturer Narrative

The report of inoperable ipg was confirmed.Analysis of the returned ipg found 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.The ipg logs confirmed that the date the device entered into service app was the day of the lead revision surgery (b)(6) 2021.As a result of this finding, actions have been taken to prevent reoccurrence.There is sufficient instruction in the clinician's manual regarding use of electrosurgery devices during surgical procedures.

Manufacturer Narrative

The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 2017.

• Brand Name: PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR
• Type of Device: SCS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 12522928
• MDR Text Key: 273084861
• Report Number: 1627487-2021-17226
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2022
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: A000100422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 09/23/2021
• Supplement Dates Manufacturer Received: 10/28/2021; 12/02/2021
• Supplement Dates FDA Received: 10/29/2021; 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487/06/02/2017/001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 68 KG