MAUDE Adverse Event Report: MPRI SPRINT QUATTRO SECURE; DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 6947M55

Device Problems Mechanical Problem (1384); Pacing Problem (1439); Device Contamination with Body Fluid (2317)

Patient Problems Arrhythmia (1721); Cardiac Arrest (1762)

Event Date 12/07/2017

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that at the time of device replacement, when the set screw was loosened, the physician tried to disconnect the device from the lead but was unable to do so.During this time ventricular pacing was not provided and the patient went into arrest for approximately one minute and cardiac massage was performed.It was suspected the setscrew was not loosened enough, it was further loosened and pulled but could not be disconnected from the device.The grommet was removed with forceps and the setscrew was found to be detached from the screw hole.When the lead was again pulled it separated from the device, external pacing was applied, ventricular pacing started, the patient regained consciousness and medication was administered.It was also reported when the lead and device were separated coagulated blood was found to have attached to the lead connector and to the electrode of the lead connector pin.Additionally, body fluid was found inside the connector.The device was replaced, the lead remains in use and no further patient complications have been reported as a result of this event.

• Brand Name: SPRINT QUATTRO SECURE
• Type of Device: DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7254462
• MDR Text Key: 99560232
• Report Number: 2649622-2018-00731
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P920015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/06/2014
• Device Model Number: 6947M55
• Device Catalogue Number: 6947M55
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2017
• Date Device Manufactured: 04/17/2012
• 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; Life Threatening; Required Intervention
• Patient Age: 80 YR