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

Model Number PLATINIUM VR 1240

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/11/2021

Event Type  Injury  

Event Description

Reportedly, a successful rf ablation procedure was performed on (b)(6) 2021 between 11am and 1pm.After the procedure, a warning message was shown upon interrogation: message [68]: 'technical problem.Defibrillation system may be ineffective.Contact microport crm.' however normal icd functioning was observed.The stimulation mode was left programmed in vvi mode at 30 min-1 and the icd therapies were reactivated.The device was replaced on (b)(6) 2021 and will be returned for analysis.Preliminary analysis of provided data revealed that the icd operation was compromised.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, a successful rf ablation procedure was performed on (b)(6) 2021 between 11am and 1pm.After the procedure, a warning message was shown upon interrogation: message [68]: 'technical problem.Defibrillation system may be ineffective.Contact microport crm.' however normal icd functioning was observed.The stimulation mode was left programmed in vvi mode at 30 min-1 and the icd therapies were reactivated.The device was replaced on (b)(6) 2021 and will be returned for analysis.Preliminary analysis of provided data revealed that the icd operation was compromised.

• 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: 12163685
• MDR Text Key: 261449485
• Report Number: 1000165971-2021-00559
• Device Sequence Number: 1
• Product Code: MRM
• UDI-Device Identifier: 08031527014395
• UDI-Public: (01)08031527014395(11)160318(17)171018
• 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
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2017
• Device Model Number: PLATINIUM VR 1240
• Device Catalogue Number: PLATINIUM VR 1240
• Device Lot Number: S0163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Date Manufacturer Received: 09/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention