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

Model Number 3664

Device Problem Material Fragmentation (1261)

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

Event Date 05/27/2022

Event Type  Injury  

Event Description

Related manufacturer reference number: 1627487-2022-03569, 1627487-2022-03570.It was reported the patient experienced ineffective stimulation due to lead migration.X-rays confirmed the leads migrated.During the surgery it was noticed the ipg had a lead fragment in one the headers.Both the ipg and leads were found to have fibrotic material entwined.Surgical intervention took place wherein the ipg and leads were explanted and replaced to address the issue.

Manufacturer Narrative

Confirmation of migration by the lab cannot be made with product testing as this issue is not product related; however, for warranty purpose analysis of the ipg was performed.Analysis of the returned ipg found minor tooling marks on the can as a result of the explant procedure, the device successfully communicated with all lab utilities, and when functionally tested on the automated test equipment (ate), all tests passed.

• 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: 14799691
• MDR Text Key: 294662804
• Report Number: 1627487-2022-03571
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067020215
• UDI-Public: 05415067020215
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150004
• 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: 08/19/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2023
• Device Model Number: 3664
• Device Catalogue Number: 3664
• Device Lot Number: 7946285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/24/2022
• Supplement Dates Manufacturer Received: 08/19/2022
• Supplement Dates FDA Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• 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 Age: 50 YR
• Patient Sex: Female