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

Model Number 392423

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

A home monitoring alerted for possible lead issue due to oversensing.The patient came in for a follow up.A chest x ray was performed and the leads had pulled back.A lead revision was performed, the physician added slack and repositioned the ra and rv leads.The leads were tested with a psa before attaching to the icd and all measurements were within normal limits.The leads were tested again once inserted into the device and all measurements were normal.When the device was placed in the pocket, abnormal sensing was observed.The physician attempted to unscrew/rescrew the rv lead; he cleaned the pin and reinserted it all with the same outcome.The physician commented that the set screw of the rv lead seemed loose compared to the atrial set screw.The rv lead was connected to a psa and noise could not be reproduced.This icd was explanted and replaced.The leads were connected to the new icd and tested fine, but noise was again observed when the icd was placed in the pocket.The rv lead was capped and replaced.

Manufacturer Narrative

Upon receipt, the icd was interrogated, revealing the battery status bos.The icd was implanted for 12 months and 94 charging cycles were recorded to the device memory.The header of the icd was visually inspected.The set screws could be easily screwed in and out, there was no foreign material inside the header bores.However, the set screw of the rv channel did not show screw marks on the bottom side, indicating that it was not tightened during the implantation.The torque wrench was also inspected and did not show any anomalies.There was no indication of a material or manufacturing problem.The memory content of the device was analyzed.During the analysis of the available iegms noise was observed in the right ventricular channel.Therefore a sensing test was performed, and the device sensed the attached heart signals free of noise, proving the sensing function of the icd to be fully functional.There was no indication of a device malfunction.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal 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 conclusion, the memory content as well as the therapeutic functionality of the icd were inspected.In the available iegms the occurrence of noise was observed in the right ventricular channel.However, a thorough analysis of the icd proved the device to be fully functional.It cannot be excluded that the clinical observation resulted from a loose connection of the rv channel set screw.

• Brand Name: IPERIA 7 DR-T DF4 PROMRI
• 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: 7548808
• MDR Text Key: 109385214
• Report Number: 1028232-2018-01797
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 392423
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 08/16/2018
• Supplement Dates FDA Received: 09/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2017
• 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
• Patient Age: 74 YR