MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-16 for PLATINIUM PLATINIUM VR 1240 manufactured by Sorin Group Italia S.r.l. - Crm Facility.
[183908959]
Reportedly on (b)(6) 2020, 2 days after implantation, the patient received an inappropriate shock following lead dislodgement, which caused the icd to interpret an atrial fibrillation as a ventricular fibrillation. The lead was then repositioned and all electrical performances were normal upon leaving the operating room. During the follow-up performed on (b)(6) 2020, lead impedance and coil continuity measurements were above 3000 ohms. No sensing and flat egms were observed. On (b)(6) 2020, a re-intervention was performed and the lead was found properly screwed. Tests with a pacing system analyzer (psa) revealed regular lead performances (threshold was 1 v, 0. 5 ms; impedance was 400 ohms and detection was normal). The physician then reconnected the lead to the icd, however the same abnormal behavior was observed: lead impedance and coil continuity measurements were saturated at 3000 ohms, no sensing and flat egms were observed. The subject icd was replaced and returned for analysis. No anomaly was observed with the new icd. Preliminary analysis revealed that, due to a wrong software management under specific conditions, the device entered a blocked state, resulting in absence of pacing and sensing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000165971-2020-00262 |
| MDR Report Key | 9715217 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-16 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-01-20 |
| Date Facility Aware | 2020-01-22 |
| Date Mfgr Received | 2020-02-17 |
| Device Manufacturer Date | 2019-10-10 |
| Date Added to Maude | 2020-02-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2020-02-16 |
| Returned To Mfg | 2020-02-05 |
| Model Number | PLATINIUM VR 1240 |
| Catalog Number | PLATINIUM VR 1240 |
| Lot Number | S0403 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Required No Informationntervention | 2020-02-16 |