MAUDE Adverse Event Report: ABBOTT MEDICAL PROCLAIM 7 IMPLANTABLE PULSE GENERATOR; SCS IPG

Model Number	3667
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided when the evaluation is completed.
Event or Problem Description
It was reported the patient's implantable pulse generator (ipg) would be replaced due to a broken ipg header port plug.Surgical intervention planned, but not yet scheduled.
Additional 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.
Additional Manufacturer Narrative
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.
Event or Problem Description
Additional information received identified the patient's scs system generator was successfully replaced, and the reported issue resolved.
Additional Manufacturer Narrative
The allegation that a port plug was stuck inside the header of the ipg was confirmed.As received, the ipg had a 1.3 inch section of a port plug stuck inside port 1-8.As received, the port plug could not be removed.Destructive analysis was performed to remove the port plug for further inspection.The fracture of the port plug is consistent with damage being caused by attempting to remove the port plug while the set screw is still fully engaged.The tooling and compression marks are consistent with efforts tried to retrieve the broken part of the port plug from the header port.The exact cause of the reported issue could not be conclusively determined.No issue found with the device history record review.The ipg was manufactured and tested according to the current manufacturing specifications, and passed all manufacturing test and visual inspection requirements.

• Brand Name: PROCLAIM 7 IMPLANTABLE PULSE GENERATOR
• Common Device Name: SCS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10708649
• Report Number: 1627487-2020-32697
• Device Sequence Number: 19743946
• Product Code: LGW
• UDI-Device Identifier: 05415067023254
• UDI-Public: 05415067023254
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/10/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/10/2020
• Device Model Number: 3667
• Device Catalogue Number: 3667
• Device Lot Number: 6629105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 12/11/2020; 01/25/2021; 04/01/2021; 06/03/2021
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 12/16/2020; 02/04/2021; 04/21/2021; 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other