MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 5 IMPLANTABLE PULSE GENERATOR; SCS IPG

Model Number	3665
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	08/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.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 implantable pulse generator was showing end of life.Patient lost stimulation as a result.The device was explanted, and a new device was implanted.There were no complications during the procedure.Patient was stable.
Additional Manufacturer Narrative
The reported observation of ¿end of service¿ 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 at which time therapy is inhibited.The estimated longevity range would have been.5 years +/-.25-year per ¿ 90205144, when assuming 1000-ohm program impedances, for model 3660, assuming 1000-ohm program impedances.For model 3662.The total stimulation on time was 185.35 days or.5 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 5 IMPLANTABLE PULSE GENERATOR
• Common Device Name: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10393861
• Report Number: 1627487-2020-23769
• Device Sequence Number: 13949390
• Product Code: LGW
• UDI-Device Identifier: 05415067023247
• UDI-Public: 05415067023247
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2020

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: 07/07/2021
• Device Model Number: 3665
• Device Catalogue Number: 3665
• Device Lot Number: 7066768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 10/19/2020
• 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