MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL PROTECTA XT DR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	D314DRG
Medical Device Problem Codes	Pacing Problem (1439); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient needed pulmonary treatment using another manufacturing company "vest" that uses pneumatic air pressure to clear the lungs.While wearing the vest, the patient's implantable cardioverter defibrillator (icd) rate response feature was pacing at the upper sensor rate.The rate response was turned off during the treatment with the vest as this resolved the issue.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.

• Brand Name: PROTECTA XT DR
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• MDR Report Key: 6625621
• Report Number: 9614453-2017-02103
• Device Sequence Number: 10918820
• Product Code: LWS
• UDI-Device Identifier: 00613994678188
• UDI-Public: 00613994678188
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2017

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: 02/28/2012
• Device Model Number: D314DRG
• Device Catalogue Number: D314DRG
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2017
• Supplement Date Received by Manufacturer: 04/15/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 10/04/2017
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 82