MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS SENSIA IPG; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	SESR01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pocket Erosion (2013)
Date of Event	08/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient experienced pocket erosion.The implantable pulse generator (ipg) was explanted and replaced.The replacement was repositioned to a sub-muscular placement.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: he device was returned and analyzed.Returned product analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SENSIA IPG
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC SINGAPORE OPERATIONS; 49 changi south avenue 2; nasaco tech centre; singapore 48605 6; SG 486056
• MDR Report Key: 9085921
• Report Number: 3008973940-2019-02569
• Device Sequence Number: 14068251
• Product Code: NVZ
• UDI-Device Identifier: 00643169709065
• UDI-Public: 00643169709065
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2019

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: Lay User/Patient
• Device Expiration Date: 04/28/2019
• Device Model Number: SESR01
• Device Catalogue Number: SESR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Initial Date Received by Manufacturer: 08/25/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 407658 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 38