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

Model Number	3665
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.
Event or Problem Description
It was reported ((b)(6)) the patient¿s ipg would not communicate with the patient programmer or clinician programmer.Multiple replacement programmers were tried to no avail.The physician decided to replace the ipg with a new one in (b)(6) 2018 (exact date unknown).
Event or Problem Description
Follow up information identified the patient's ipg was replaced with a new one resolving the issue.

• Brand Name: PROCLAIM¿ 5
• Common Device Name: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 7662341
• Report Number: 1627487-2018-06244
• Device Sequence Number: 2514749
• Product Code: LGW
• UDI-Device Identifier: 05415067023247
• UDI-Public: 05415067023247
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 12/17/2018

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: 10/03/2018
• Device Model Number: 3665
• Device Lot Number: 5649565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 09/17/2018; 12/05/2018
• Initial Report FDA Received Date: 07/04/2018
• Supplement Report FDA Received Date: 09/19/2018; 12/17/2018
• 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