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

Model Number 394099

Device Problem Component Missing (2306)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/10/2014

Event Type  Injury  

Event Description

Ous mdr - it was reported that the fixation sleeve of the lead got into the vascular system of the patient during the implantation and could no longer be removed.After removal of the lead from the body, the fixation sleeve was no longer on the lead.No worsening of the patient's state of health was reported.A new lead was implanted.

Manufacturer Narrative

Until today, the medical product is not available for analysis and could therefore not be studied.Since the device was not returned, the analysis is based on the existing production documents.They did not show any anomalies that could be related to the complaint.All manufacturing steps were carried out correctly.Due to the production process design, it can be assumed that the lead fixation sleeve was mounted to the lead in accordance with the technical specifications.Introducing the lead fixation sleeve into the vascular system is, in our opinion, only possible under increased mechanical pressure during the insertion of the lead into the vascular system, due to the geometry of the lead fixation sleeve.There are no comparable complaints, during which the lead fixation sleeve made its way into the vascular system.Summary: the device complained about was not available for analysis.A check of the production documents did not indicate any manufacturing error.

• Brand Name: PROTEGO PROMRI S 65
• Type of Device: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-12 359; GM D-12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 3999447
• MDR Text Key: 4712374
• Report Number: 1028232-2014-002787
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 394099
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2013
• 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