MAUDE Adverse Event Report: IPG MFG SWITZERLAND INSYNC SENTRY; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number 7298

Device Problems Pacing Inadequately (1442); Battery Problem (2885)

Patient Problems Atrial Fibrillation (1729); Pain (1994); Electric Shock (2554)

Event Date 02/21/2014

Event Type  Injury  

Event Description

It was reported that during the replacement procedure of the device for elective replacement indicator (eri), while the electrosurgery system was in use, the patient¿s body had a reaction that was seen, like they got an electrical shock.The patient stated that they experienced pain at that moment.The procedure continued.When all device leads were released, it was noted that the patient experienced a heart rhythm characteristic of atrial fibrillation and normal heart rhythm was restored with medication following the procedure.The device was explanted and replaced.No further patient complications have been reported as a result of this event.(b)(6) 2014-(b)(4): procedure of exchanging crtd device that reached eri ((b)(4)) to cardia crtd peak plasma blade was used.While the blade was in use in one moment there was sth.Like a short circuit that could be noticed by patient body reaction and complain from the patient that it hurt him.Procedure was continued when all leads were released from tissue before disconnecting lead with the device doctor took a look on the monitor to check the rhythm then he noticed an a fib conducted to ventricles about 150-160/min.Patient were in sinus rhythm before the procedure.Although the exact moment of rhythm change has not been seen there seems to be a correlation with using a plasma blade.Leads impedance were stable before implant and stayed on the same level after device exchange.History: unknown injury: yes, atrial fibrilation rhythm intervention required: not specified patient outcome: alive - with injury (b)(4).Geo event: it was reported that during the procedure of exchanging crtd device that reached eri ((b)(4)) to cardia crtd.A peak plasma blade was used.While the blade was in use in one moment there was sth.Like a short circuit that could be noticed by patient body reaction and complain from the patient that it hurt him.Procedure was continued when all leads were released from tissue before disconnecting lead with the device doctor took a look on the monitor to check the rhythm then he noticed an a fib conducted to ventricles about 150-160/min.Patient was in sinus rhythm before the procedure.Although the exact moment of rhythm change has not been seen there seems to be a c correlation with using a plasma blade.Leads impedance were stable before implant and stayed on the same level after device exchange.After the procedure, patient stayed in afib rhythm, it was planned to terminate it (medicate or cv).Geo prelim assesment: review of the std-file revealed the following: >> no patient alert.>> high a-sic/day >> review of the episode v-egm shows at/af manual excerpt peak plasma blade the use of electrosurgery in the presence of internal or external cardiac pacemakers is potentially hazardous.Interference from the electrical current can cause device malfunction.Consult the cardiac pacemaker manufacturer for further information before proceeding with the surgery.Geo prelim conclusion: no indication that icd or plasma blade induced the af, likely patient condition related (b)(4) 2014 - (b)(4): clarification from (b)(4).Can you confirm that during a pacemaker generator change out, the patient started with normal heart rhythm, and upon activation of the plasma blade the patient¿s heart rhythm changed (it went into a fib).(update: it was an exchange of crt-d device patient was in sinus rhythm prior to the procedure and according to information from hcp never had any afib history.As i wrote in the report, the exact moment of rhythm change hasn¿t been noticed when you use plasma blade, it is used many times during procedure to cut and coag if needed.Procedure time when plasma blade was used in this case, i assume was 10-15 min.Doctor noticed the rhythm change more less after that time when he was about to disconnect old device.) is it believed that activation of the plasma blade cause the patient¿s heart rhythm to change? (update: yes it is believed there is a correlation with use of plasma blade and rhythm change).Did this occur with every activation of the plasma blade or was it just one occurrence? (update: the exact moment of rhythm change hasn¿t been noticed when you use plasma blade it is used many times during procedure to cut and coag if needed but for sure it was not like that every time you touched patient with the blade the rhythm was changing).Was the patient under anesthesia or were they awake? how did the patient complain of pain? (update: patient was awake in that moment i described of sth.Like a short circuit it could be seen (body reaction like a little electric shock) then doctor asked patient if he felt something, patient confirmed to feel a pain at that moment despite local anesthesia.) what steps were taken to return the patient¿s heart rhythm to normal? or did it return to normal on its own once the pacemaker and leads were exchanged? (update: after procedure was finished sinus rhythm was restored with medications) (b)(4) 2014 - (b)(4)- pe is reportable as the shock to the patient was unintentional and potentially caused the patient to enter a fib, requiring medication to resume sinus rhythm post op.Reported incident: interference of the plasma blade shocked the patient and potentially caused patient to go into a-fib.Post operatively, the patient resumed normal heart rhythm via medication.Complaint analysis determination (generator): complaint not confirmed complaint analysis determination (device): complaint not confirmed complaint analysis summary (generator): the generator was not returned for investigation.Complaint analysis summary (device): the device was not returned for investigation lhr/dhr review (generator): product number and serial number unknown; therefore, unable to be performed.Lhr/dhr review (device): no associated manufacturing or servicing issues.Reportability decision (fda) (generator): reportable reportability decision (fda) (device): reportable investigation summary (generator): the generator involved in this incident was utilized in a case that resulted in serious injury, an unintentional shock to the patient resulting in patient going into a-fib and requiring medical intervention in order to resume sinus rhythm, therefore, the incident is reportable based on patient outcome.The generator involved in this incident was not returned for product analysis, therefore, it could not be confirmed if the generator malfunctioned.Although it could not be confirmed if the generator malfunctioned, there was an unintended consequence with the utilization of the system (device and generator), in that it was reported that the patient felt a shock (unintentional), and the patient¿s heart rhythm went into a-fib requiring medical intervention in order to restore sinus rhythm.An applicable failure mode is documented within the hazard analysis documentation and categorized with a critical severity rating which supports the decision of the incident as reportable.Investigation summary (device): the device involved in this incident was utilized in a case that resulted in serious injury, an unintentional shock to the patient resulting in patient going into a-fib and requiring medical intervention in order to resume sinus rhythm, therefore the incident is reportable based on patient outcome.The device involved in this incident was not returned for product analysis, therefore, it could not be confirmed if the device malfunctioned.Although it could not be confirmed if the device malfunctioned, there was an unintended consequence with the utilization of the system (device and generator), in that it was reported that the patient felt a shock (unintentional), and the patient¿s heart rhythm went into a-fib requiring medical intervention in order to restore sinus rhythm.An applicable failure mode is documented within the hazard analysis documentation and categorized with a critical severity rating which supports the decision of the incident as reportable.Corrective action plan (generator): complaint not confirmed therefore no formal corrective action will be issued in conjunction with this complaint.Complaint will be tracked and trended.Corrective action plan (device): complaint not confirmed therefore no formal corrective action will be issued in conjunction with this complaint.Complaint will be tracked and trended.

Manufacturer Narrative

This event occurred outside the us.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.This model number is not approved for distribution in the united states, however, it is similar to a device marketed in the u.S.The event is being reported due to an alleged malfunction.(b)(4).

• Brand Name: INSYNC SENTRY
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM DISEASE MGMT; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: nashoane fulwood-kelley ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635260583
• MDR Report Key: 3744148
• MDR Text Key: 20009740
• Report Number: 9614453-2014-00880
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2014

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2011
• Device Model Number: 7298
• Device Catalogue Number: 7298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2014
• Initial Date FDA Received: 04/11/2014
• Date Device Manufactured: 08/11/2009
• 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