MAUDE Adverse Event Report: MICROPORT CRM S.R.L. PLATINIUM; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number PLATINIUM DR 1540

Device Problem Failure to Transmit Record (1521)

Patient Problem No Information (3190)

Event Date 07/02/2019

Event Type  malfunction  

Event Description

Reportedly, the associated home monitor is properly paired to the subject defibrillator, but no remote follow-up can be performed on the patient.Additionally, a new home monitor has been shipped to the patient, but the same behavior was observed.

Event Description

Reportedly, the associated home monitor is properly paired to the subject defibrillator, but no remote follow-up can be performed on the patient.Additionally, a new home monitor has been shipped to the patient, but the same behavior was observed.

Manufacturer Narrative

Please refer to the attached preliminary analysis report.

Manufacturer Narrative

The complaint was re-opened following the reception of additional information: on (b)(6) 2020, the patient came to the hospital and a third home monitor was provided and tested on site.The home monitor could correctly be paired to the subject icd.However, no patient initiated transfer (pit) could be performed, even if the home monitor stayed at the same distance from the patient, as for when the pairing was performed: the progression lights of the home monitor were lighting in green, but then the pit button started blinking in red.The rf from the icd was deactivated, then reactivated, but the observed behavior persisted.All electrical devices that were close to the home monitor and the icd were off, and the network was observed to be properly working.

Event Description

Reportedly, the associated home monitor is properly paired to the subject defibrillator, but no remote follow-up can be performed on the patient.Additionally, a new home monitor has been shipped to the patient, but the same behavior was observed.

Manufacturer Narrative

Preliminary analysis revealed that the observed impossibility to perform a patient initiated transfer (pit) or remote follow-ups most probably resulted from an issue with the data transmitted by the implant to any home monitor, leading to the abortion of all the attempted communications.

Event Description

Reportedly, the associated home monitor is properly paired to the subject defibrillator, but no remote follow-up can be performed on the patient.Additionally, a new home monitor has been shipped to the patient, but the same behavior was observed.

Event Description

Reportedly, the associated home monitor is properly paired to the subject defibrillator, but no remote follow-up can be performed on the patient.Additionally, a new home monitor has been shipped to the patient, but the same behavior was observed.

Manufacturer Narrative

Please refer to the attached analysis report.

• Brand Name: PLATINIUM
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): MICROPORT CRM S.R.L.; via crescentino s.n.; .; saluggia (vc) 13040 ; IT 13040
• MDR Report Key: 9291660
• MDR Text Key: 177173837
• Report Number: 1000165971-2019-00621
• Device Sequence Number: 1
• Product Code: MRM
• UDI-Device Identifier: 08031527014401
• UDI-Public: (01)08031527014401(11)190214(17)200914
• Combination Product (y/n): N
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2020
• Device Model Number: PLATINIUM DR 1540
• Device Catalogue Number: PLATINIUM DR 1540
• Device Lot Number: S0352
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/14/2019
• Event Location: Home
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1