MAUDE Adverse Event Report: MEDTRONIC, INC. SENSIA DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	SEDR01
Medical Device Problem Codes	Incorrect Measurement (1383); Unable to Obtain Readings (1516); Battery Problem (2885); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2015
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 implantable pulse generator (ipg) is now at elective replacement indicator (eri) and no lead trend data is available for the atrial lead.Data was able to be obtained from a save to disk and it showed that the device had a diagnostic reset occur several years ago.Additionally, several years ago the atrial lead had triggered an atrial lead warning, had far field r-wave (ffrw) oversensing, noise and high/undefined impedance.There was also a polarity switch that occurred as a direct result of the atrial lead integrity issue.The ipg was explanted and replaced.The atrial lead remains in use with the new ipg.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: performance data collected from the device was received and analyzed.Analysis of the device memory showed the battery indicator signifying that it is time for device replacement.Analysis of the device memory had an observation relating to diagnostics/data collection.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.Analysis of the device revealed normal battery depletion.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.

• Brand Name: SENSIA DR
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 7617046
• Report Number: 2182208-2018-01152
• Device Sequence Number: 1624234
• Product Code: NVZ
• UDI-Device Identifier: 00613994177957
• UDI-Public: 00613994177957
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/03/2018

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: Lay User/Patient
• Device Model Number: SEDR01
• Device Catalogue Number: SEDR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 07/16/2018; 08/15/2018; 08/08/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 07/17/2018; 08/17/2018; 10/03/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 42 YR