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

Model Number PARADYM DR 8550

Device Problems Failure to Interrogate (1332); Pacing Problem (1439)

Patient Problem Dizziness (2194)

Event Date 02/16/2021

Event Type  Injury  

Event Description

Reportedly, during a follow-up performed on (b)(6) 2021, the subject icd could not be interrogated using the inductive telemetry head.An orange led was lit but no green led was lit.The icd could not be interrogated using another programmer, and no reaction was observed when a magnet was placed over the implant.Spontaneous rhythm was observed and the heart rate of the patient ranged between 70min-1 to 75min-1.It was suspected that the battery was depleted.During the previous follow-up performed on 17 november 2020, a magnet rate of 82min-1 was measured, as well as a battery voltage of 2.82v.The atrium and the ventricle were sensed 100% of the time.The patient had been experiencing lightheadedness over the past three months.Noise oversensing episodes had been recorded since several years and were being followed-up.

Manufacturer Narrative

Explantation date (d7 field) was updated: the subject icd was explanted on 26 february 2021.During the re-intervention, the ventricular lead was tested with a pacing system analyzer (psa) and no anomalies were observed.The atrial and ventricular leads were abandoned in the patient's body.

Event Description

Reportedly, during a follow-up performed on (b)(6) 2021, the subject icd could not be interrogated using the inductive telemetry head.An orange led was lit but no green led was lit.The icd could not be interrogated using another programmer, and no reaction was observed when a magnet was placed over the implant.Spontaneous rhythm was observed and the heart rate of the patient ranged between 70min-1 to 75min-1.It was suspected that the battery was depleted.During the previous follow-up performed on (b)(6) 2020, a magnet rate of 82min-1 was measured, as well as a battery voltage of 2.82v.The atrium and the ventricle were sensed 100% of the time.The patient had been experiencing lightheadedness over the past three months.Noise oversensing episodes had been recorded since several years and were being followed-up.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, during a follow-up performed on (b)(6) 2021, the subject icd could not be interrogated using the inductive telemetry head.An orange led was lit but no green led was lit.The icd could not be interrogated using another programmer, and no reaction was observed when a magnet was placed over the implant.Spontaneous rhythm was observed and the heart rate of the patient ranged between 70min-1 to 75min-1.It was suspected that the battery was depleted.During the previous follow-up performed on (b)(6) 2020, a magnet rate of 82min-1 was measured, as well as a battery voltage of 2.82v.The atrium and the ventricle were sensed 100% of the time.The patient had been experiencing lightheadedness over the past three months.Noise oversensing episodes had been recorded since several years and were being followed-up.

Manufacturer Narrative

Expertise of the returned device revealed that a failure at the level of a discrete electronic component (high voltage capacitor) is suspected.Review of manufacturing records confirmed that the device was manufactured and released according to all applicable procedures.

Event Description

Reportedly, during a follow-up performed on 16 february 2021, the subject icd could not be interrogated using the inductive telemetry head.An orange led was lit but no green led was lit.The icd could not be interrogated using another programmer, and no reaction was observed when a magnet was placed over the implant.Spontaneous rhythm was observed and the heart rate of the patient ranged between 70min-1 to 75min-1.It was suspected that the battery was depleted.During the previous follow-up performed on (b)(6) 2020, a magnet rate of 82min-1 was measured, as well as a battery voltage of 2.82v.The atrium and the ventricle were sensed 100% of the time.The patient had been experiencing lightheadedness over the past three months.Noise oversensing episodes had been recorded since several years and were being followed-up.

• Brand Name: PARADYM
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; via crescentino s.n.; .; saluggia (vc), 13040 ; IT 13040
• MDR Report Key: 11386793
• MDR Text Key: 241508700
• Report Number: 1000165971-2021-00339
• Device Sequence Number: 1
• Product Code: MRM
• 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: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2013
• Device Model Number: PARADYM DR 8550
• Device Catalogue Number: PARADYM DR 8550
• Device Lot Number: 2634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/16/2021
• Event Location: Hospital
• Date Manufacturer Received: 06/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention