MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG IFORIA 7 DR-T PROMRI DF4; ICD

Model Number 390075

Device Problems Under-Sensing (1661); Low impedance (2285)

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

Event Date 05/08/2015

Event Type  malfunction  

Event Description

Ous mdr - on (b)(6), ra pacing failure with undersensing and lead impedance under 200 ohms were observed.The ra-lead looked slightly pulled compared to the x-ray which was taken on the day of operation.The next day a revision was performed.The set screw was contaminated by blood.All the measurements of the ra-lead was fine after cleaning and removal from the icd.Therefore the icd was exchanged for a new one.The ra-lead and the rv-lead are still implanted.

Manufacturer Narrative

Upon receipt, the device was interrogated, revealing the battery status bos, five charging cycles were recorded to the device memory.The header of the icd was visually inspected.The inspection revealed residues of blood inside the is-1 ra header bore and on the is-1 ra set screw thread as well as underneath the sealing plug of that set screw, indicating a blood inclusion through the is-1 ra header bore.Beside this, the analysis showed no anomalies.Especially the dimensions of the header bores were confirmed to be within the specifications.There was no indication of a material or manufacturing problem.The memory content of the device was inspected.The inspection revealed a decreased atrial pacing impedance of <200 ohm on (b)(6), 2015, confirming the clinical observation.Therefore the impedance measurement functions of the device were tested and proved to be fully functional.For this reason, it can be assumed that the decreased atrial pacing impedance resulted from the observed blood contamination of the is-1 ra header bore.However, the time of blood inclusion was not determinable.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be flawless and in amplitude and frequency as programmed.A fibrillation signal was applied and the device delivered a defibrillation shock as specified,documenting a correct sensing and shock delivery.In particular, the specified energy level was reached.In summary, the clinical observation most probably resulted from a blood inclusion into the is-1 ra header bore.The exact time of blood inclusion was not determinable.However, a thorough analysis of the icd, especially of the impedance measurement functions and the therapeutic functionality proved the device to be fully functional.There was no indication of a device malfunction.

• Brand Name: IFORIA 7 DR-T PROMRI DF4
• Type of Device: ICD
• 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: 4824755
• MDR Text Key: 21934895
• Report Number: 1028232-2015-01818
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 390075
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2015
• 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