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

Model Number	3665
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is included in the neuromodulation implantable pulse generator (ipg) inaccurate elective replacement indicator advisory notice issued by abbott on 12 september 2017.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 diagnostics indicated the elective replacement indicator (eri) triggered earlier than intended.The device had the appropriate level of battery voltage to provide therapy.The device was explanted and replaced.
Additional Manufacturer Narrative
The device is included in the neuromodulation implantable pulse generator (ipg) inaccurate elective replacement indicator advisory notice issued by abbott on 12 september 2017.

• Brand Name: PROCLAIM 5 IPG
• Common Device Name: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 8436411
• Report Number: 1627487-2019-03578
• Device Sequence Number: 2051459
• Product Code: LGW
• UDI-Device Identifier: 05415067023247
• UDI-Public: 05415067023247
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2019

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: 09/18/2019
• Device Model Number: 3665
• Device Lot Number: 6133761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1627487/09/12/2017/001-C
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR