MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM AND INFINITY AND DRG; SCS IPG

Model Number	3665
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	06/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 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 the patient could no longer connect with their ipg after an unrelated procedure.As a result, surgical intervention was taken to replace the ipg.
Additional Manufacturer Narrative
The reported event for inoperable ipg was confirmed.It was determined the device was running the service application software.This condition is consistent with electrocautery use during surgery.Per event details, the ipg no longer communicated following an unrelated surgery.As a result of this finding, actions have been taken to prevent reoccurrence.

• Brand Name: PROCLAIM AND INFINITY AND DRG
• Common Device Name: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 8832808
• Report Number: 1627487-2019-08504
• Device Sequence Number: 16221042
• 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: 2017
• 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): 10/15/2019

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: 06/29/2019
• Device Model Number: 3665
• Device Lot Number: 6031824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 10/15/2019
• 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: 1627487/06/02/2017/001-C
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other