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 | 4843352 |
MDR Text Key | 5874416 |
Report Number | 1000165971-2015-00359 |
Device Sequence Number | 1 |
Product Code |
MRM
|
Combination Product (y/n) | N |
Reporter Country Code | IT |
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 |
Report Date |
05/19/2015 |
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 | 02/13/2015 |
Device Model Number | ISOLINE 2CT6 |
Device Catalogue Number | ISOLINE 2CT6 |
Device Lot Number | 2590 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Distributor Facility Aware Date | 05/19/2015 |
Event Location |
Hospital
|
Initial Date Manufacturer Received |
07/02/2015
|
Initial Date FDA Received | 06/15/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 07/07/2015
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/13/2012 |
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;
|
|
|