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

Model Number	PARADYM RF DR 9550
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Reportedly, upon interrogation of the device, multiple warning messages were displayed including: [27] the device was reinitialized 1 time since the beginning of life, [59] reset occurred on (b)(6) 2018, [a1] low shock impedance on (b)(6) 2018 and [a4] max shock energy ineffective on (b)(6) 2018.The patient is hospitalized and reportedly may have been experiencing runs of vt and may have been receiving shocks.It is also possible the patient was externally cardioverted however, this was not confimed.Preliminary analysis revealed that overload conditions were met on (b)(6) 2018.And confirmed that the reset occurred.This reset was related to the detection of corrupted data in the device memories.
Event or Problem Description
Reportedly, upon interrogation of the device, multiple warning messages were displayed including: [27] the device was reinitialized 1 times since the beginning of life, [59] reset occurred on (b)(6)2018, [a1] low shock impedance on (b)(6)2018 and [a4] max shock energy ineffective on (b)(6)2018.The patient is hospitalized and reportedly may have been experiencing runs of vt and may have been receiving shocks.It is also possible the patient was externally cardioverted however, this was not confirmed.Preliminary analysis revealed that overload conditions were met on (b)(6)2018.And confirmed that the reset occurred.This reset was related to the detection of corrupted data in the device memories.

• Brand Name: PARADYM RF
• 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: 7925078
• Report Number: 1000165971-2018-00889
• Device Sequence Number: 16609134
• Product Code: MRM
• UDI-Device Identifier: 08031527012254
• UDI-Public: (01)08031527012254(11)140109(17)150209
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/09/2015
• Device Model Number: PARADYM RF DR 9550
• Device Catalogue Number: PARADYM RF DR 9550
• Device Lot Number: 2788
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/10/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 11/08/2018
• 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: Required Intervention