MAUDE Adverse Event Report: ST. JUDE MEDICAL, PLANO, TX EONC; IMPLANTABLE PULSE GENERATOR

Model Number 3688

Device Problems Migration or Expulsion of Device (1395); Low Battery (2584); Battery Problem (2885); Power Problem (3010)

Patient Problems Pulmonary Embolism (1498); Dyspnea (1816); Pulmonary Dysfunction (2019); Tachycardia (2095)

Event Date 05/22/2018

Event Type  Injury  

Event Description

Planned surgery (b)(6) 2018 to explant eonc 1pg due to battery exhaustion.Lead dislodgement occurred.Case suspended, manufacturer contacted requesting new leads.Patient hospitalized with surgical drains per routine.Battery exhaustion, surgical replacement, lead dislodgement, hospitalization noted as possible risks in protocol.Manufacturer told sponsor (b)(6) 2018 that device components (eonc/libra dbs leads) being phased out and not located to provide to site.Suggested sjm infinity dbs system technology and reviewed by sponsor/team/patient.Late evening (b)(6) 2018, patient had elevated heart rate.Rapid response team called for svt sustained rate of 188/chest tightness.Metoprolol administered, heart rate down to sr 88.Ecg shows probable left ventricular hypertrophy.Patient to operating room (b)(6) 2018 for implantation of sjm infinity ipg/dbs leads, using swift lock anchors and sutures to secure.Successful implantation and documentation of ipg/lead stimulation occurred before leaving operating room.Patient initially extubated post-op, developed stridor, reintubated.To operating room (b)(6) 2018 for extubation.Sats remained low and tracheotomy ultimately performed.Ultrasound (b)(6) 2018 noted nonocclusive thrombus in left popliteal vein and ct same date noted diffuse pulmonary arterial emboli in both distal main pulmonary arteries with extension into upper and lower lobe branches, lungs clear.Patient discharged (b)(6) 2018.The battery exhaustion of device and delay in obtaining equipment for surgical implantation could have caused stress to patient resulting in elevated heart rate and stridor, resulting in tracheotomy.We believe pulmonary embolism could be due to lack of activity.

• Brand Name: EONC
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, PLANO, TX
• MDR Report Key: 7579235
• MDR Text Key: 110594723
• Report Number: 7579235
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734402460
• UDI-Public: (01)05414734402460
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2017
• Device Model Number: 3688
• Device Catalogue Number: 3688
• Device Lot Number: 527540
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/31/2018
• Distributor Facility Aware Date: 05/22/2018
• Device Age: 3 NA
• Event Location: Hospital
• Date Report to Manufacturer: 05/29/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 67