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

Model Number 3664

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/23/2023

Event Type  Injury  

Event Description

Related manufacturer reference number: 1627487-2023-05274, related manufacturer reference number: 1627487-2023-05275.It was reported that during an implant procedure on (b)(6) 2023 following a trial, the last contact of the lead was damaged while removing it from the extension used for the trial period.Reportedly, the physician elected to keep the same lead to complete the procedure.Additionally, there was difficulty inserting and removing the new extension from the ipg header.When the physician attempted to remove the new extension from the ipg header, two contacts of the extension broke and remains lodged in the ipg header/port.A new extension was connected to a different header/port to complete the procedure.Reportedly, therapy is running without any issue.

Manufacturer Narrative

Analysis conclusion it was reported that during an implant procedure on (b)(6) 2023 following a trial, the last contact of the lead was damaged while removing it from the extension used for the trial period.Reportedly, the physician elected to keep the same lead to complete the procedure.Additionally, there was difficulty inserting and removing the new extension from the ipg header.When the physician attempted to remove the new extension from the ipg header, two contacts of the extension broke and remains lodged in the ipg header/port.A new extension was connected to a different header/port to complete the procedure.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 event could not be conclusively determined.Additionally, the device history record of the device was reviewed to confirm that all manufacturing steps were completed and there were no non-conformances noted that could have contributed to this issue.

Manufacturer Narrative

Corrected data: d6a.

• 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: 18096760
• MDR Text Key: 327699317
• Report Number: 1627487-2023-05276
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067020215
• UDI-Public: 05415067020215
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3664
• Device Lot Number: T00005403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2023
• 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: Male