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

Model Number	D334DRG
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 6940-45 lead, implanted: (b)(6) 2000.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient called to report that the implantable cardioverter defibrillator (icd) battery longevity was less than expected.A follow up with the patient's healthcare provider yielded that the device is at recommended replacement time (rrt).The device is scheduled to be replaced.The device remains in the patient.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the 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.
Event or Problem Description
The device was removed and a new device was implanted.

• Brand Name: PROTECTA 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: 7254953
• Report Number: 9614453-2018-00199
• Device Sequence Number: 1213791
• Product Code: LWS
• UDI-Device Identifier: 00613994678157
• UDI-Public: 00613994678157
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2018

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: 03/28/2012
• Device Model Number: D334DRG
• Device Catalogue Number: D334DRG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Initial Date Received by Manufacturer: 12/08/2017
• Supplement Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 04/25/2018
• 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: 54 YR