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

Model Number 392423

Device Problem Programming Issue (3014)

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

Event Date 05/19/2017

Event Type  malfunction  

Event Description

Ous mdr - (b)(6) 2017 the patient was hospitalized for a non-cardiac reason.After surgery the device was checked, therapy was found disabled.Therapy was turned on after surgery and the rep that visited took ram dump for further investigation.Biotronik was not inform of a revision.

Manufacturer Narrative

The icd was not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device as well as on the returned device data.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process which might be related to the clinical observation.The returned device data have been analyzed.The follow up data clearly documents that the anti-tachycardia therapy was manually disabled on (b)(6) 2017 upon interrogation of the icd.The programming device promoted the following message at 9:39 am, which was confirmed with: yes.Until then the icd was active.In conclusion, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.The analysis of the returned device data revealed no indication of a device malfunction.

• Brand Name: IPERIA 7 DR-T DF4 PROMRI
• Type of Device: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359 ; DE 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 6644198
• MDR Text Key: 77654266
• Report Number: 1028232-2017-01999
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: DE
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: Yes
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2015
• 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): Required Intervention