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

Model Number ISOLINE 2CR6

Device Problems Fracture (1260); Nonstandard Device (1420)

Patient Problem No Information (3190)

Event Date 06/07/2017

Event Type  Injury  

Event Description

Reportedly, the subject defibrillation lead was extracted due to lead fracture.

Event Description

Reportedly, the subject defibrillation lead was extracted due to lead fracture.

• 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 (SALUGGIA ITALY); via crescentino s.n.; .; saluggia, 13040 ; IT 13040
• Manufacturer Contact: david thierman ; via crescentino s.n.; .; saluggia, 13040 ; IT 13040 ; 0161487077
• MDR Report Key: 6673795
• MDR Text Key: 78609592
• Report Number: 1000165971-2017-00522
• Device Sequence Number: 0
• Product Code: MRM
• Reporter Country Code: US
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/07/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ISOLINE 2CR6
• Device Catalogue Number: ISOLINE 2CR6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/07/2017
• Event Location: Hospital
• Date Manufacturer Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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