MAUDE Adverse Event Report: SORIN CRM OVATIO; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number OVATIO DR 6550

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2014

Event Type  Injury  

Event Description

During a follow-up performed on (b)(6) 2014, a warning message was displayed indicating that the defibrillation system would be ineffective (due to abnormally low shock impedance).In the corresponding episode (classified as ventricular fibrillation), it was observed that capacitors were charged to 34 joules, but no shock could be delivered.The arrhythmia spontaneously ceased.It was also reported that all stored episodes were misclassified as ventricular fibrillation, whereas they correspond to supra-ventricular arrhythmias.Patient care recommendations were provided (evaluate the benefit of a re-intervention for replacing the defibrillation lead).A new follow-up was performed on (b)(6) 2014.Vf induction test was performed.Vf was successfully induced with a 0,6j shock on t-wave; but no shock therapy (34j) could be delivered to reduce the arrhythmia due to overload detection (i.E.The detection of low shock impedance).An external defibrillation shock was reportedly delivered; return to slow rhythm majority was then observed.Re-intervention was performed on (b)(6) 2014.Icd and defibrillation lead were both replaced.The icd will be returned to sorin crm for expertise.

Event Description

During a follow-up performed on (b)(6) 2014, a warning message was displayed indicating that the defibrillation system would be ineffective (due to abnormally low shock impedance).In the corresponding episode (classified as ventricular fibrillation), it was observed that capacitors were charged to 34 joules, but no shock could be delivered.The arrhythmia spontaneously ceased.It was also reported that all stored episodes were misclassified as ventricular fibrillation, whereas they correspond to supra-ventricular arrhythmias.Patient care recommendations were provided (evaluate the benefit of a re-intervention for replacing the defibrillation lead).A new follow-up was performed on (b)(6) 2014.Vf induction test was performed.Vf was successfully induced with a 0,6j shock on t-wave; but no shock therapy (34j) could be delivered to reduce the arrhythmia due to overload detection (i.E.The detection of low shock impedance).An external defibrillation shock was reportedly delivered; return to slow rhythm majority was then observed.Re-intervention was performed on (b)(6) 2014.Icd and defibrillation lead were both replaced.The icd will be returned to sorin crm for expertise.

Event Description

During a follow-up performed on (b)(6) 2014, a warning message was displayed indicating that the defibrillation system would be ineffective (due to abnormally low shock impedance).In the corresponding episode (classified as ventricular fibrillation), it was observed that capacitors were charged to 34 joules, but no shock could be delivered.The arrhythmia spontaneously ceased.It was also reported that all stored episodes were misclassified as ventricular fibrillation, whereas they correspond to supra-ventricular arrhythmias.Patient care recommendations were provided (evaluate the benefit of a re-intervention for replacing the defibrillation lead).A new follow-up was performed on (b)(6) 2014.Vf induction test was performed.Vf was successfully induced with a 0,6j shock on t-wave; but no shock therapy (34j) could be delivered to reduce the arrhythmia due to overload detection (i.E.The detection of low shock impedance).An external defibrillation shock was reportedly delivered; return to slow rhythm majority was then observed.Re-intervention was performed on (b)(6) 2014.Icd and defibrillation lead were both replaced.The icd will be returned to sorin crm for expertise.

Manufacturer Narrative

Preliminary analysis of the returned device confirmed it operated as specified.

• Brand Name: OVATIO
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): SORIN CRM; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer (Section G): SORIN CRM 98, RUE MAURICE ARNOUX 92120 MONTROUGE FRANCE; 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: 4100906
• MDR Text Key: 4834088
• Report Number: 1000165971-2014-00537
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PP980049
• 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,Followup
• Report Date: 08/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/03/2010
• Device Model Number: OVATIO DR 6550
• Device Catalogue Number: OVATIO DR 6550
• Device Lot Number: M090408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/29/2014
• Event Location: Hospital
• Date Manufacturer Received: 02/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2009
• 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): Required Intervention