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

Model Number PLATINIUM VR 1240

Device Problems High impedance (1291); Failure to Sense (1559); Inappropriate/Inadequate Shock/Stimulation (1574); No Pacing (3268)

Patient Problem No Information (3190)

Event Date 01/20/2020

Event Type  Injury  

Event Description

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.

Event Description

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 impendance 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 impendance 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.

Event Description

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.(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.

Manufacturer Narrative

Returned device analysis confirmed that the device was in a permanent blocked state, resulting in absence of pacing and sensing.

• Brand Name: PLATINIUM
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• MDR Report Key: 9715217
• MDR Text Key: 183908959
• Report Number: 1000165971-2020-00262
• Device Sequence Number: 1
• Product Code: MRM
• UDI-Device Identifier: 08031527014395
• UDI-Public: (01)08031527014395(11)191010(17)210510
• Combination Product (y/n): N
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2021
• Device Model Number: PLATINIUM VR 1240
• Device Catalogue Number: PLATINIUM VR 1240
• Device Lot Number: S0403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/22/2020
• Event Location: Hospital
• Date Manufacturer Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention