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

Model Number 3661

Device Problems Battery Problem (2885); Wireless Communication Problem (3283)

Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388)

Event Date 06/29/2022

Event Type  Injury  

Event Description

It was reported the patient lost therapy.Diagnostics indicated the, "replace generator.The generator has reached its end of service," message displayed on external devices.It is unknown if the ipg depleted prematurely.In addition it was reported the patient kept stimulation on high causing the battery to deplete.Surgery may take place later to address the issue.

Manufacturer Narrative

Date of event is estimated.

Event Description

Additional information revealed that the patient underwent surgical intervention wherein the ipg was explanted and replaced, resolving the issue.

Manufacturer Narrative

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.

• Brand Name: PROCLAIM¿ 5 IMPLANTABLE PULSE GENERATOR, HEADER M
• 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: 15135720
• MDR Text Key: 296947560
• Report Number: 1627487-2022-03751
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020208
• UDI-Public: 05415067020208
• 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: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2023
• Device Model Number: 3661
• Device Catalogue Number: 3661
• Device Lot Number: 7922990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• 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
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 93 KG