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

Model Number ISOLINE 2CT6

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285)

Patient Problem Electric Shock (2554)

Event Date 08/22/2014

Event Type  Injury  

Event Description

Upon interrogation of the associated icd (paradym vr (sn (b)(4)) on (b)(4) 2014, warning messages were displayed stating that 23 device resets occurred and that low shock impedance was measured relative to the subject lead.Device memories were empty.Patient reported that shocks were delivered.According to preliminary analysis results, a device hardware issue was suspected.Patient care recommendations were provided (evaluation of the benefit of device replacement).A reintervention was performed to replace the icd system.The subject lead could not be removed and remains inactive.

Event Description

Upon interrogation of the associated icd (paradym vr (sn (b)(4)) on (b)(4) 2014, warning messages were displayed stating that 23 device resets occurred and that low shock impedance was measured relative to the subject lead.Device memories were empty.Patient reported that shocks were delivered.According to preliminary analysis results, a device hardware issue was suspected.Patient care recommendations were provided (evaluation of the benefit of device replacement).A reintervention was performed to replace the icd system.The subject lead could not be removed and remains inactive.

• 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 1304 0; 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: 4263898
• MDR Text Key: 5008889
• Report Number: 1000165971-2014-00639
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PP980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/28/2014

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: 07/06/2012
• Device Model Number: ISOLINE 2CT6
• Device Catalogue Number: ISOLINE 2CT6
• Device Lot Number: 2385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/28/2014
• Initial Date Manufacturer Received: 01/23/2015
• Initial Date FDA Received: 11/20/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2009
• 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; Required Intervention