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

Model Number PARADYM RF DR 9550

Device Problems Defibrillation/Stimulation Problem (1573); Low impedance (2285); Reset Problem (3019)

Patient Problem Palpitations (2467)

Event Date 12/26/2014

Event Type  Injury  

Event Description

It was reported that, on (b)(6) 2014, patient was driving when he felt palpitations which led to a car accident.Upon icd interrogation, it was observed that shocks were delivered by the icd but were inefficient; also a warning message related to "low shock impedance" was displayed.An external cardioversion (200 joules) was then delivered and was successful.Ventricular noise was observed in episodes stored in icd memories.After the external cardioversion, warning messages were displayed indicating "55 device resets" and the presence of a "technical issue".Preliminary analysis results and patient care recommendations have been provided to the complainant (replacement show a revision of the rv lead (isoline) is planned.An analysis of the icd operation was requested.Ld be evaluated for both the icd and the isoline lead).The icd and the isoline lead were reportedly explanted on (b)(6) 2015.

Event Description

It was reported that, on (b)(6) 2014, patient was driving when he felt palpitations which led to a car accident.Upon icd interrogation, it was observed that shocks were delivered by the icd but were inefficient; also a warning message related to "low shock impedance" was displayed.An external cardioversion (200 joules) was then delivered and was successful.Ventricular noise was observed in episodes stored in icd memories.After the external cardioversion, warning messages were displayed indicating "55 device resets" and the presence of a "technical issue." a revision of the rv lead (isoline) is planned.An analysis of the icd operation was requested.Preliminary analysis results and patient care recommendations have been provided to the complainant (replacement should be evaluated for both the icd and the isoline lead).The icd and the isoline lead were reportedly explanted on (b)(6) 2015.

• Brand Name: PARADYM
• Type of Device: 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
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; parc d'affaires noveos 4 avenue réaumur; .; clamart 9214 0; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 4450394
• MDR Text Key: 5383064
• Report Number: 1000165971-2015-00037
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: PP060027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/29/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2015
• Device Model Number: PARADYM RF DR 9550
• Device Catalogue Number: PARADYM RF DR 9550
• Device Lot Number: 2833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/29/2014
• Event Location: Other
• Initial Date Manufacturer Received: 04/14/2015
• Initial Date FDA Received: 01/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization