MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 7; SCS IPG

Model Number	3667
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	05/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a loss of therapy due to their ipg becoming inoperable.As a result, surgical intervention was taken to replace the ipg.The issue has been addressed.
Additional Manufacturer Narrative
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 reported observation of ¿ipg replaced due to eri¿ was not confirmed.Review of the implantable pulse generator (ipg) diagnostic logs showed at no time had the device declared an elective replacement indication (eri).It was also confirmed the lowest battery voltage logged in diagnostics was 2.954v.The eri voltage threshold is 2.7v +/- 30mv and below.The device exhibited normal characteristics during analysis.It has been concluded that this event is not reportable as analysis of the returned device revealed no anomalies.Review of the implantable pulse generator (ipg) diagnostic logs showed at no time had the device declared an elective replacement indication (eri).It was also confirmed the lowest battery voltage logged in diagnostics was 2.954v.The eri voltage threshold is 2.7v +/- 30mv and below.The device exhibited normal device characteristics during analysis.

• Brand Name: PROCLAIM 7
• Common Device Name: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 8641100
• Report Number: 1627487-2019-06154
• Device Sequence Number: 1831298
• Product Code: LGW
• UDI-Device Identifier: 05415067023254
• UDI-Public: 05415067023254
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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: 06/16/2018
• Device Model Number: 3667
• Device Lot Number: 5536562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 08/20/2019
• 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
• Patient Age: 59 YR