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

Model Number PLATINIUM DR 1540

Device Problem Pacing Problem (1439)

Patient Problem Syncope (1610)

Event Date 09/12/2016

Event Type  Injury  

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, the patient came to the hospital in the night between (b)(6) 2016 because of lipothymia.The subject icd was programmed in safer-r mode, and the cardiologist suspected that the patient was sensitive to avb commutations.Since the patient has a severe cardiac condition, the cardiologist wants to avoid ventricular stimulation.Therefore he reprogrammed the icd in ddd mode with an av delay of 205ms.On (b)(6) 2016, the patient was ready to be discharged, but then he collapsed.It was reported that he was in asystolia, he received an external cardiac massage and drugs and was hospitalized again.The medical team used an external monitoring device to check patient's cardiac rhythm.Atrial pacing was reportedly observed, but there was no ventricular activity.Upon icd interrogation and during tests, no anomaly was reportedly observed.The cardiologist wants to know what caused the asystolia and how to reprogram the icd to avoid it, and to avoid as well ventricular pacing.

• Brand Name: PLATINIUM
• 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 92140 ; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 5971766
• MDR Text Key: 55422642
• Report Number: 1000165971-2016-00573
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PP980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2017
• Device Model Number: PLATINIUM DR 1540
• Device Catalogue Number: PLATINIUM DR 1540
• Device Lot Number: S0173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/13/2016
• Date Manufacturer Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2016
• 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; Required Intervention