MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PLATINIUM; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number	PLATINIUM DR 1510
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
During a routine follow-up of a platinium dr 1510 sn (b)(4) on (b)(6) 2017, warning message "62 excessive charge time detected.Defibrillation system potentially ineffective." was displayed at interrogation.Reporter wants to know why this message was displayed and what this indicated.The last charge time displayed on the overview screen was 9.8 seconds.No detection listed for this device.The last charge to 42 j was listed as being on the day of implant, (b)(6) 2017.A real time charge time test to 42 joules with a charge time of 10 seconds and duration of 16 seconds was conducted.This charge time test appeared to be normal.All other follow-up tests were normal for this device.Preliminary analysis showed that the reported warning was displayed due to an incomplete charge that occurred before implantation, whereas the whole system was probably not in place.Charge time upon implantation was correct.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
During a routine follow-up of a platinium dr 1510 sn (b)(4) on (b)(6) 2017, warning message ¿62 excessive charge time detected.Defibrillation system potentially ineffective.¿ was displayed at interrogation.Reporter wants to know why this message was displayed and what this indicated.The last charge time displayed on the overview screen was 9.8 seconds.No detection listed for this device.The last charge to 42 j was listed as being on the day of implant, (b)(6) 2017.A real time charge time test to 42 joules with a charge time of 10 seconds and duration of 16 seconds was conducted.This charge time test appeared to be normal.All other follow-up tests were normal for this device.Preliminary analysis showed that the reported warning was displayed due to an incomplete charge that occurred before implantation, whereas the whole system was probably not in place.Charge time upon implantation was correct.

• Brand Name: PLATINIUM
• Common Device Name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• MDR Report Key: 6680486
• Report Number: 1000165971-2017-00525
• Device Sequence Number: 11277626
• Product Code: MRM
• UDI-Device Identifier: 08031527015521
• UDI-Public: (01)08031527015521(11)170714(17)180214
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/14/2018
• Device Model Number: PLATINIUM DR 1510
• Device Catalogue Number: PLATINIUM DR 1510
• Device Lot Number: S0198
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/05/2017
• Initial Date Received by Manufacturer: 06/05/2017
• Supplement Date Received by Manufacturer: 07/13/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 07/21/2017
• 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