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	09/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.Event date is an estimation.
Event or Problem Description
It was reported that the patient's ipg was inoperable.As a result, the ipg was explanted and replaced.Therapy was restored following the procedure.
Additional Manufacturer Narrative
The reported event of ipg end of life (eol) was confirmed.As received, the battery voltage was below the eri voltage threshold and the ipg had declared end of service (eos).An estimate of longevity determined that the ipg had normal battery depletion and reached its normal end of life (eol).

• 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: 10601580
• Report Number: 1627487-2020-31986
• Device Sequence Number: 14216660
• 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: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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: 06/29/2019
• Device Model Number: 3665
• Device Catalogue Number: 3665
• Device Lot Number: 6031824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 11/19/2020
• 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