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

Model Number	3663
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
It was reported that the patient was experiencing uncomfortable therapy.As a result, the patient underwent surgical intervention during which the ipg was explanted.
Additional Manufacturer Narrative
The reported observation of ¿trembling in her pain area (leg) even when the stimulation was off¿ was not confirmed.The root cause of the observation was not ascertained.Using a clinicians programmer, the system impedance test results were within the expected range.The device was subjected to a functional test on automated test equipment (ate).This tester verifies the electrical performance of the control/communication circuitry, and output signal integrity.All portions of ate testing passed.The ate specifically tests the ipg output and system impedances on all 16 electrodes including the ipg can connection.The lead system was not returned with the ipg.

• 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: 17101008
• Report Number: 1627487-2023-02782
• Device Sequence Number: 7812839
• Product Code: LGW
• UDI-Device Identifier: 05415067020239
• UDI-Public: 05415067020239
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2021
• Device Model Number: 3663
• Device Catalogue Number: 3663
• Device Lot Number: 7102593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/23/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2019
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown