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

Model Number ISOLINE 2CT6

Device Problems Over-Sensing (1438); Low impedance (2285)

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." 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 subject isoline lead).

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 subject isoline lead).

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 subject isoline lead).

Manufacturer Narrative

Additional information was received relative to patient treatment.A re-intervention was performed to correct the issue and the subject lead and associated icd were explanted on (b)(6) 2015.The subject lead has been returned to the manufacturer for analysis.

• Brand Name: ISOLINE
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; via crescentino s.n.; .; saluggia 13040 ; IT 13040
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; via crescentino s.n.; .; saluggia 1304 0; IT 13040
• Manufacturer Contact: david thierman ; via crescentino s.n.; .; saluggia 13040 ; IT 13040 ; 0161487077
• MDR Report Key: 4429992
• MDR Text Key: 5278248
• Report Number: 1000165971-2015-00027
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: PP980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,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: 07/10/2009
• Device Model Number: ISOLINE 2CT6
• Device Catalogue Number: ISOLINE 2CT6
• Device Lot Number: 2156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/29/2014
• Event Location: Other
• Initial Date Manufacturer Received: 04/24/2015
• Initial Date FDA Received: 01/19/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/18/2015; 05/13/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0928-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization