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

Model Number	D334DRG
Medical Device Problem Codes	Delayed Charge Time (2586); Battery Problem (2885)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2019
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 device reached recommended replacement time (rrt) and then had an excessive charge time alert with a charge time of greater than 16 seconds.The device was removed and a new device was implanted.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
Product event summary: the device was returned and analyzed.Analysis of the device found high internal battery resistance.If information is provided in the future, a supplemental report will be issued.

• 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: 8302699
• Report Number: 9614453-2019-00358
• Device Sequence Number: 13719026
• Product Code: LWS
• UDI-Device Identifier: 00613994678157
• UDI-Public: 00613994678157
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2019

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: 03/15/2019
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 01/09/2019; 06/03/2019
• Initial Report FDA Received Date: 02/04/2019
• Supplement Report FDA Received Date: 02/04/2019; 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4470-52 LEAD, 0184 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 79