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

Model Number	3667
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	05/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided on the final report.
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 device.
Additional Manufacturer Narrative
Product performance engineering has confirmed normal device longevity.This event is no longer reportable.The reported observation of ¿inoperable 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.It was noted the device was utilized in a continuous mode throughout the implant period.Stimulation and programming is inhibited when eol is declared.The longevity based on the programming and usage would have been 1 year.The total stimulation on time was 447.7 days or 1.23 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.All portions of ate testing passed.

• Brand Name: PROCLAIM 7 IPG
• Common Device Name: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 8683269
• Report Number: 1627487-2019-06735
• Device Sequence Number: 2233069
• 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: 2018
• 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): 08/30/2019

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: 09/11/2019
• Device Model Number: 3667
• Device Lot Number: 6119092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 08/30/2019
• 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