MAUDE Adverse Event Report: ABBOTT MEDICAL PROCLAIM¿ 5 IMPLANTABLE PULSE GENERATOR; SCS IPG

Model Number	3665
Medical Device Problem Codes	Battery Problem (2885); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter phone number: (b)(6).Date of event is estimated.
Event or Problem Description
It was reported the ipg had reached end of life.In turn, the ipg was explanted and replaced to address the issue.
Additional Manufacturer Narrative
The reported observation of ¿end of life ipg¿ was confirmed.The root cause of the reported observation was due to the device having normal battery depletion to the end of life (eol).The device provided therapy per the programming up to the eol declaration date.The device longevity by determining the energy factors over the implant period.The estimated longevity range would have been 1 year up to 2.8 years +/-.25-year per ¿ 90205144, for model 3665.The total stimulation on time was 2.02 years, suggesting the device had normal battery depletion to the end of life.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.The device exhibited normal device characteristics during testing.

• Brand Name: PROCLAIM¿ 5 IMPLANTABLE PULSE GENERATOR
• 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 12476272
• Report Number: 1627487-2021-17017
• Device Sequence Number: 14381143
• Product Code: LGW
• UDI-Device Identifier: 05415067023247
• UDI-Public: 05415067023247
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2021

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: 06/14/2018
• Device Model Number: 3665
• Device Catalogue Number: 3665
• Device Lot Number: 6127957
• 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: 08/27/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2016
• 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