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

Model Number PLATINIUM DR 1510

Device Problems High impedance (1291); Failure to Sense (1559); No Pacing (3268)

Patient Problem No Information (3190)

Event Date 02/11/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, the subject device was implanted as a replacement of a previous icd with the a non-microport atrial lead and the previous vigila 2cr ventricular lead already implanted on (b)(6) 2013.The new atrial lead was implanted by the left axillary access in the bundle of his and the subject device was implanted as a replacement of the previous icd.Measurements of the atrial lead in the bundle of his were a threshold of 3.5 v at 1 ms, r-wave amplitude of 1 mv, and impedance of 689 ohms.Atrioventricular node ablation was performed in order to get a modulation with a rate of 80-90 bpm.Just after the ablation, malfunction of the subject device was noticed as all impedance values were measured above 3000 ohms, and no egm signal was observed, so are-intervention was decided.On (b)(6) 2019, during the re-intervention, the leads were checked with a pacing system analyzer and the measurements were normal.When connected to the subject device, lead impedances were again high.Finally the device was replaced by another platinum dr 1510 and all the impedance values were normal.

Event Description

On (b)(6)2019, the subject device was implanted as a replacement of a previous icd with the a non-microport atrial lead and the previous vigila 2cr ventricular lead already implanted on (b)(6)2013.The new atrial lead was implanted by the left axillary access in the bundle of his and the subject device was implanted as a replacement of the previous icd.Measurements of the atrial lead in the bundle of his were a threshold of 3.5 v at 1 ms, r-wave amplitude of 1 mv, and impedance of 689 ohms.Atrioventricular node ablation was performed in order to get a modulation with a rate of 80-90 bpm.Just after the ablation, malfunction of the subject device was noticed as all impedance values were measured above 3000 ohms, and no egm signal was observed, so a re-intervention was planned.On (b)(6)2019, during the re-intervention, the leads were checked with a pacing system analyzer and the measurements were normal.When connected to the subject device, lead impedances were again high.Finally the device was replaced by another platinium dr 1510 and all the impedance values were normal.

Manufacturer Narrative

The preliminary analysis of the returned device confirmed the reported pacing and sensing failure.

Manufacturer Narrative

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

On (b)(6) 2019, the subject device was implanted as a replacement of a previous icd with the a non-microport atrial lead and the previous vigila 2cr ventricular lead already implanted on (b)(6) 2013.The new atrial lead was implanted by the left axillary access in the bundle of his and the subject device was implanted as a replacement of the previous icd.Measurements of the atrial lead in the bundle of his were a threshold of 3.5 v at 1 ms, r-wave amplitude of 1 mv, and impedance of 689 ohms.Atrioventricular node ablation was performed in order to get a modulation with a rate of 80-90 bpm.Just after the ablation, malfunction of the subject device was noticed as all impedance values were measured above 3000 ohms, and no egm signal was observed, so a re-intervention was planned.On (b)(6) 2019, during the re-intervention, the leads were checked with a pacing system analyzer and the measurements were normal.When connected to the subject device, lead impedances were again high.Finally the device was replaced by another platinium dr 1510 and all the impedance values were normal.

Event Description

On (b)(6) 2019, the subject device was implanted as a replacement of a previous icd with the a non-microport atrial lead and the previous vigila 2cr ventricular lead already implanted on (b)(6) 2013.The new atrial lead was implanted by the left axillary access in the bundle of his and the subject device was implanted as a replacement of the previous icd.Measurements of the atrial lead in the bundle of his were a threshold of 3.5 v at 1 ms, r-wave amplitude of 1 mv, and impedance of 689 ohms.Atrioventricular node ablation was performed in order to get a modulation with a rate of 80-90 bpm.Just after the ablation, malfunction of the subject device was noticed as all impedance values were measured above 3000 ohms, and no egm signal was observed, so a re-intervention was planned.On (b)(6) 2019, during the re-intervention, the leads were checked with a pacing system analyzer and the measurements were normal.When connected to the subject device, lead impedances were again high.Finally the device was replaced by another platinium dr 1510 and all the impedance values were normal.

Manufacturer Narrative

Please refer to the attached investigation report.- attachment: [20190926 - file-2019-00516 - analysis_and_closure_report_resp-2019-01155.Pdf].

• 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: 8394730
• MDR Text Key: 137961859
• Report Number: 1000165971-2019-00128
• Device Sequence Number: 1
• Product Code: MRM
• UDI-Device Identifier: 08031527014364
• UDI-Public: (01)08031527014364(11)170728(17)190228
• 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,Followup
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: PLATINIUM DR 1510
• Device Catalogue Number: PLATINIUM DR 1510
• Device Lot Number: S0274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/11/2019
• Event Location: Hospital
• Date Manufacturer Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention