MAUDE Adverse Event Report: SORIN CRM S.A.S SYMPHONY; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number SYMPHONY DR 2550

Device Problem Premature Discharge of Battery (1057)

Patient Problem Palpitations (2467)

Event Date 07/01/2020

Event Type  Injury  

Event Description

Reportedly, the estimated residual longevity was 20 months +/- 1 month, the battery impedance at 4.99 kohms and the magnet 94 min-1 in (b)(6) 2019.The atrial output was 2.0 v / 0.35 ms, the ventricular output 3.0 v, 0.35 ms and the atrial and ventricular pacing percentages were 20% and 100%, respectively.A follow-up was scheduled for (b)(6) 2020 but missed due to the covid-19 outbreak.Then, the patient presented to the hospital due to palpitations and the subject pacemaker was found in standby mode.

Event Description

Reportedly, the estimated residual longevity was 20 months +/- 1 month, the battery impedance at 4.99 kohms and the magnet 94 min-1 in (b)(6) 2019.The atrial output was 2.0 v / 0.35 ms, the ventricular output 3.0 v, 0.35 ms and the atrial and ventricular pacing percentages were 20% and 100%, respectively.A follow-up was scheduled for (b)(6) 2020 but missed due to the covid-19 outbreak.Then, the patient presented to the hospital due to palpitations and the subject pacemaker was found in standby mode.

• Brand Name: SYMPHONY
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): SORIN CRM S.A.S; 98 rue maurice arnoux; .; montrouge 92120 ; FR 92120
• MDR Report Key: 11044852
• MDR Text Key: 222628351
• Report Number: 1000165971-2020-00822
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• PMA/PMN Number: P950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2009
• Device Model Number: SYMPHONY DR 2550
• Device Catalogue Number: SYMPHONY DR 2550
• Device Lot Number: S080215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/10/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention