MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-04 for PLATINIUM PLATINIUM DR 1540 manufactured by Sorin Group Italia S.r.l. - Crm Facility.
[182001648]
Reportedly, upon device interrogation, the icd was found operating in nominal mode. No alert stating that a reset occurred was displayed. It seems that the physician saw the programmer screen becoming red in the corners and had validated a message stating that a safety mode will be programmed. The observed event may have resulted from an accidental press on the emergency button on the inductive programming head.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1000165971-2020-00250 |
MDR Report Key | 9665870 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2020-02-04 |
Date of Report | 2020-03-19 |
Date of Event | 2020-01-10 |
Date Facility Aware | 2020-01-10 |
Date Mfgr Received | 2020-03-04 |
Device Manufacturer Date | 2016-03-07 |
Date Added to Maude | 2020-02-04 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | LAURA OUAKI |
Manufacturer Street | PARC D'AFFAIRES NOVEOS 4 AVENUE R . |
Manufacturer City | CLAMART 92140 |
Manufacturer Country | FR |
Manufacturer Postal | 92140 |
Manufacturer Phone | 146013429 |
Manufacturer G1 | SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY |
Manufacturer Street | PARC D'AFFAIRES NOVEOS 4 AVENUE R . |
Manufacturer City | CLAMART 92140 |
Manufacturer Country | FR |
Manufacturer Postal Code | 92140 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | PLATINIUM |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Product Code | MRM |
Date Received | 2020-02-04 |
Model Number | PLATINIUM DR 1540 |
Catalog Number | PLATINIUM DR 1540 |
Lot Number | S0157 |
Device Expiration Date | 2017-10-07 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | SORIN GROUP ITALIA S.R.L. - CRM FACILITY |
Manufacturer Address | PARC D'AFFAIRES NOVEOS 4 AVENUE R?AUMUR . CLAMART 92140 FR 92140 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-02-04 |