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

Model Number	3665
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/27/2018
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 communication issues with their ipg.As a result, the ipg was replaced.Issue has been resolved.
Additional Manufacturer Narrative
The reported event of no ipg communication was confirmed.As received, the ipg was unable to communicate with a lab clinician programmer.Testing identified characteristics consistent with a failure in the ble circuitry since the advertising channels were not being broadcasted at the correct frequencies.

• 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: 8276652
• Report Number: 1627487-2019-00785
• Device Sequence Number: 13941264
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/21/2020

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: 06/06/2020
• Device Model Number: 3665
• Device Catalogue Number: 3665
• Device Lot Number: 6483000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 01/30/2019; 01/10/2020
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 02/01/2019; 01/21/2020
• 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