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

Model Number ISOLINE 2CR5

Device Problems Failure to Sense (1559); No Pacing (3268)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2014

Event Type  Injury  

Event Description

The physician reported that a re-intervention was performed to correct loss of sensing relative to the subject lead.Reportedly, a bipolar pacing lead was implanted to replace the pacing/sensing function of the subject lead.The defibrillation function of the subject lead remains active.

Manufacturer Narrative

(b)(4).

Event Description

The physician reported that a re-intervention was performed to correct loss of sensing relative to the subject lead.Reportedly, a bipolar pacing lead was implanted to replace the pacing/sensing function of the subject lead.The defibrillation function of the subject lead remains active.

Event Description

The physician reported that a re-intervention was performed to correct loss of sensing relative to the subject lead.Reportedly, a bipolar pacing lead was implanted to replace the pacing/sensing function of the subject lead.The defibrillation function of the subject lead remains active.

• 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: 3852998
• MDR Text Key: 4684637
• Report Number: 1000165971-2014-00322
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2010
• Device Model Number: ISOLINE 2CR5
• Device Catalogue Number: ISOLINE 2CR5
• Device Lot Number: 2276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/15/2014
• Event Location: Hospital
• Date Manufacturer Received: 02/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2008
• 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): Required Intervention