MAUDE Adverse Event Report: MPRI SPRINT FIDELIS; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number 694965

Device Problems Fracture (1260); High impedance (1291)

Patient Problems Pain (1994); Distress (2329); No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2015

Event Type  Injury  

Manufacturer Narrative

The initial reported event of high pacing impedance and fracture was previously submitted via a remedial action exemption (rae) summary report.The manufacturer has voluntarily discontinued this rae, so supplemental information is being submitted via a 30 day report.Product event summary: the lead was returned but destructive analysis could not be performed due to legal restrictions.Visual analysis was conducted and the setscrew marks on the connector pin were too proximal.Concomitant medical products: d274trk icd; implanted on (b)(6) 2010.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during the implant procedure when the right ventricular (rv) lead was connected to the new device the rv lead had high pacing impedance and a confirmed fracture.Additionally, the left ventricular (lv) lead would not pace after connecting to the new device as the hvb coil is the anode for that lead.A new rv lead was attempted to then be implanted but due to multiple abandoned leads and tight access under the clavicle the new rv lead could not advance to the right ventricle.The attempted lead was removed.The physician decided to connect the chronic leads to the new device with pacing function only and monitor the patient for ventricular arrhythmias.No patient complications have been reported as a result of this event.It was further reported that the right ventricular (rv) lead was now explanted and replaced.No patient complications have been reported as a result of this event.It was later reported by the patient that they had pain and suffering due to their ¿defective lead¿ and that when the lead was replaced several years ago it took longer than expected because the lead was wrapped around their heart organ.

• Brand Name: SPRINT FIDELIS
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9197760
• MDR Text Key: 162800464
• Report Number: 2649622-2019-19007
• Device Sequence Number: 1
• Product Code: LWS
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/26/2006
• Device Model Number: 694965
• Device Catalogue Number: 694965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2004
• 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; Required Intervention
• Patient Age: 60 YR