MAUDE Adverse Event Report: ABBOTT MEDICAL PROCLAIM¿ 7 IMPLANTABLE PULSE GENERATOR, HEADER M; SCS IPG

Model Number	3663
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	08/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated product #1 pi main (b)(4).A patient's ipg became inoperable was reported to abbott.The ipg was not set to surgery mode while the patient underwent an unrelated surgical procedure.No intervention is scheduled at this time.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.During processing of this incident, attempts were made to obtain complete patient information.Further information was requested but not received.
Event or Problem Description
It was reported that the patient underwent an unrelated surgery and did not place the ipg into surgery mode.As a result, the ipg became inoperable.Surgical intervention may take place at a later date to address the issue.

• Brand Name: PROCLAIM¿ 7 IMPLANTABLE PULSE GENERATOR, HEADER M
• Common Device Name: SCS 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: 17662084
• Report Number: 1627487-2023-04143
• Device Sequence Number: 15004644
• Product Code: LGW
• UDI-Device Identifier: 05415067020239
• UDI-Public: 05415067020239
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/05/2020
• Device Model Number: 3663
• Device Lot Number: 6563204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1627487/06/02/2017/001-C
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female