MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PLEXA PROMRI S 65; ICD LEAD

Model Number 402266

Device Problems High impedance (1291); Battery Problem (2885); High Capture Threshold (3266)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/04/2017

Event Type  malfunction  

Event Description

Ous mdr - it was reported that approx.2 months after the implantation remarkable impedance and threshold values at elevated power consumption were noted.The lead and the icd were explanted.

Manufacturer Narrative

The lead and the icd were returned and subjected to an extensive analysis.The lead was inspected visually, electrically, and mechanically.During this inspection, no deviations from the technical specifications were found that could be linked to the clinical complaint.The lead was to specifications and in working order.The returned icd was status interrogated.The device status was bos and three charging processes were documented in the device's memory.In the next step, the icds ability to deliver therapy and its power consumption were examined.The antibradycardia output signal was in working order and in accordance with the values programmed.A fibrillation signal was applied and the device reacted as per specifications with a defibrillation shock.The specified energy level was attained and the charging time for the defibrillation shock was normal and as expected.The examination of the icd power consumption showed intermittently slightly elevated values.An additional test of the impedance measurement functions showed nothing unusual.The impedance measurement functions behaved without incident during testing.After these steps, the icd was opened to conduct a visual and electrical analysis of the electronic module.We do not yet have the results from this analysis.As soon as the icd analysis has been completed, the update will be updated and shared with reference to inlexa 3 hf-t qp df4 is4 (sn 60906395).

• Brand Name: PLEXA PROMRI S 65
• Type of Device: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 6990103
• MDR Text Key: 90795399
• Report Number: 1028232-2017-03885
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P980023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 402266
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization