MAUDE Adverse Event Report: ABBOTT MEDICAL PROCLAIM¿ DRG IMPLANTABLE PULSE GENERATOR; DRG IPG

Model Number 3664

Device Problem Battery Problem (2885)

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

Event Date 04/15/2024

Event Type  Injury  

Manufacturer Narrative

Reporter phone number (b)(6).Date of event is estimated.

Event Description

It was reported the device displayed the end of service (eos) message and it is unknown if the device depleted prematurely.The ipg was deemed inoperable, and patient lost therapy.As a result, surgical intervention was undertaken wherein the ipg was explanted and replaced.Effective therapy was restored post operatively.

• Brand Name: PROCLAIM¿ DRG IMPLANTABLE PULSE GENERATOR
• Type of Device: DRG 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 19165602
• MDR Text Key: 340847128
• Report Number: 1627487-2024-08281
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067020215
• UDI-Public: (01)05415067020215(10)T00005024(17)240914
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2024

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 Model Number: 3664
• Device Lot Number: T00005024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/15/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/15/2022
• 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