MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SENSIA DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	SEDR01
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	Ventricular Tachycardia (2132)
Date of Event	02/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device was reported as included in the field action.Based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action.It is included in the field action in the abundance of caution.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician believed that something related to the ventricular safety pacing (vsp) device feature was causing the patient to experience intermittent ventricular tachycardia (vt).The implantable pulse generator (ipg) remains is planned to be explanted and replaced as the device is also at elective replacement indicator (eri).No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
This device was reported as included in the field action noted but returned product investigation found the device did not perform as described in the field action.The device is no longer included as part of the field action.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.
Event or Problem Description
It was further reported that the ipg was explanted and replaced.

• Brand Name: SENSIA DR
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 7419055
• Report Number: 3004209178-2018-07700
• Device Sequence Number: 19194136
• Product Code: NVZ
• UDI-Device Identifier: 00613994177957
• UDI-Public: 00613994177957
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2018

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 Expiration Date: 12/28/2009
• Device Model Number: SEDR01
• Device Catalogue Number: SEDR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 07/02/2018
• 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: Z-2120-2011
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 35 YR