MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SENSIA IPG; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	SESR01
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2020
Type of Reportable Event	Malfunction
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 implantable pulse generator (ipg) is "moving around" and flips under the patients skin.The ipg remains in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was further reported that the patient symptoms were not related to an ipg performance issue.

• Brand Name: SENSIA IPG
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10217708
• Report Number: 3004209178-2020-11383
• Device Sequence Number: 11430080
• Product Code: NVZ
• UDI-Device Identifier: 00643169474260
• UDI-Public: 00643169474260
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/28/2017
• Device Model Number: SESR01
• Device Catalogue Number: SESR01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 07/02/2020; 07/06/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 07/06/2020; 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR