MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION INFINITY¿ 5 IMPLANTABLE PULSE GENERATOR; DBS IPG

Model Number	6661
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	01/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results, method, and conclusion codes along with the investigation results will be provided in final report.
Event or Problem Description
It was reported the patients ipg is unable to communicate with external devices.Troubleshooting was unable to resolve the issue.As a result, surgical intervention was undertaken during which the ipg was explanted and replaced.Surgical intervention addressed the issue.
Additional Manufacturer Narrative
The reported observation of ¿ipg does not display in the cp generator list¿ was not confirmed.The cause of the reported observation was not ascertained.The devices diagnostic logging showed a magnet was applied several times after the device had entered a bondable state.The device was subjected to a functional test on automated test equipment (ate).This tester verifies the electrical performance of the control/communication circuitry, and output signal integrity.All portions of ate testing passed.Ate testing is performed utilizing the devices bluetooth circuitry.The device exhibited normal characteristics during functional and electrical testing.Corrected data: this event is no associated with an fsca.

• Brand Name: INFINITY¿ 5 IMPLANTABLE PULSE GENERATOR
• Common Device Name: DBS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 9678141
• Report Number: 1627487-2020-01360
• Device Sequence Number: 11361915
• Product Code: MHY
• UDI-Device Identifier: 05415067020253
• UDI-Public: 05415067020253
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2020

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: 08/14/2020
• Device Model Number: 6661
• Device Catalogue Number: 6661
• Device Lot Number: 6616292
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/19/2020
• Supplement Date Received by Manufacturer: 03/17/2020; 03/26/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 03/20/2020; 03/26/2020
• 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