MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PROTEGO PROMRI SD 65/18; ICD LEAD

Model Number 399415

Device Problems Signal Artifact/Noise (1036); Premature Elective Replacement Indicator (1483)

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

Event Type  malfunction  

Event Description

Ous mdr.After an implantation period of approx 2 years, the icd indicated eri.Furthermore, vf detections, almost all of them occurring between 1 and 2 am during the night, were reported upon interrogation.Some kind of artifact was causing vf detections, which would stop during charging.Artifacts were seen on both the rv and ff channels.Icd and lead were explanted and returned to biotronik.No adverse patient side effects have been reported.The date of explant and the event date were not reported.

Manufacturer Narrative

The lead was visually inspected, revealing multiple signs of wear along the lead body.In particular in the distal area of the lead the insulation was found rubbed through.This damage can be considered to be the root cause of the documented artifacts.Based on the characteristics of this damage, it is reasonable to assume that the lead had been subject to severe mechanical stress in the implanted state.Significant motion in the area of the tricuspid valve and interaction with modified tissue should be taken into account.Diagnostic images clarifying this assumption were not available.Further damages, such as deformations of the shock coils, most likely occurred during the explantation procedure.

• Brand Name: PROTEGO PROMRI SD 65/18
• 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: 6033341
• MDR Text Key: 57621254
• Report Number: 1028232-2016-03739
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 399415
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2013
• 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