MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEART START XL; DEFIBRILLATOR

Model Number M4735A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Electric Shock (2554)

Event Date 02/13/2017

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

Event Description

It was reported to philips that during a catheter ablation, the device delivered 14 shocks to the patient.Following the procedure, a thoracic vertebral fracture was found, also indicating that chest compressions were not performed.The customer did not report a device failure and indicated they were performing a search of case reported regarding the issue.The customer is requesting if philips has received similar cases to this scenario.Note that there is no allegation of a device malfunction, but a question of if the fracture was related to defibrillation.Philips is considering this a serious injury due to the limited information received.

Manufacturer Narrative

The customer did not request a device evaluation.The customer was inquiring if philips was aware of any similar instances where fractures were observed after defibrillation (but not compressions.Philips performed a review of the complaint database and did not identify any reports of thoracic fracture related to defibrillation.In addition, two philips clinicians stated that they were not aware of any thoracic fractures related to defibrillation in their own clinical practice.Information was provided regarding the customer's request for information.There was no allegation of a device malfunction.

• Brand Name: HEART START XL
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: wendy chadbourne ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6345382
• MDR Text Key: 67833921
• Report Number: 1218950-2017-01172
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K001725
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M4735A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 71