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

Model Number 6947M55

Device Problems Break (1069); Intermittent Capture (1080); Failure to Capture (1081); Device Contamination with Body Fluid (2317); Device Dislodged or Dislocated (2923); Unstable Capture Threshold (3269)

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

Event Date 12/28/2016

Event Type  Injury  

Manufacturer Narrative

Product event summary: the full lead was returned and analyzed.The overlay tubing of the lead was extrinsically breached due to a cut.The overlay tubing of the lead was observed to have blood ingression.Visual summary analysis of the lead indicated damage at implant.

Event Description

It was reported that x-ray revealed that the right ventricular (rv) lead had dislodged.The rv lead was found to have unstable thresholds with no capture.During lead removal, the physician noticed blood inside the insulation as there was insulation damage to the lead.The lead was removed and a new lead was implanted.No patient complications have been reported as a result of this event.

Manufacturer Narrative

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

• 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: 6317715
• MDR Text Key: 67077203
• Report Number: 2649622-2017-00818
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 00643169356610
• UDI-Public: 00643169356610
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P920015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/05/2018
• Device Model Number: 6947M55
• Device Catalogue Number: 6947M55
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2016
• 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
• Treatment: DVFB1D4 ICD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR