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

Model Number 3664

Device Problems Failure to Disconnect (2541); Separation Failure (2547); Mechanical Jam (2983)

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

Event Type  Injury  

Event Description

Related manufacturer report number: 1627487-2023-00640, 1627487-2023-00642.It was reported that the patient was experiencing loss of therapy on one lead.In turn, the patient underwent surgical intervention to address the issue.During the surgery, both leads were unable to be removed from the ipg due to both the electrodes being stuck in the ipg header.As a result, the physician pulled the leads by force and the leads were frayed.The system was explanted and replaced.Effective therapy was established post-operatively.

Manufacturer Narrative

Date of event is estimated.

Manufacturer Narrative

The reported event of difficulty removing leads from ipg header was confirmed based on the as-received condition of the ipg.X-ray analysis revealed a lead terminal end contact (non-functioning) was stuck in the set screw block for port 1 (channels 1-4) and for port 2 (channels 5-8).The detached lead terminal end contacts occurred during the lead revision procedure.As received, the set screw for port 1 and port 2 were fully engaged.Normal operation of the set screws for port 1 and 2 was observed.However, further testing could not be performed since the lead terminal end contacts could not be removed from ports 1 and 2.

Manufacturer Narrative

Correction: section h6 medical device problem code should have been "2547 - separation failure" instead of "2541 - failure to disconnect".This correction is reflected in this additional report 2.

• 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 16359859
• MDR Text Key: 309369797
• Report Number: 1627487-2023-00639
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067020215
• UDI-Public: 05415067020215
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2023
• Device Model Number: 3664
• Device Catalogue Number: 3664
• Device Lot Number: 7859659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2021
• 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