MAUDE Adverse Event Report: BIOTRONIK SETROX S53; LEADS

Catalog Number 350974

Device Problems Premature Discharge of Battery (1057); Device Inoperable (1663); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Atrial Fibrillation (1729); Cardiac Arrest (1762); Death (1802); No Known Impact Or Consequence To Patient (2692); No Known Impact Or Consequence To Patient (2692)

Event Date 04/21/2011

Event Type  Death  

Event Description

The reporter stated that a relative was given a biotronik pacemaker/defibrillator and there was a 10 year warranty on it but it malfunctioned in 2 years.He had a replacement surgery and that one also malfunctioned and he was driving and ran his car into a bus and the icd was still shocking him.When he arrived at the hospital the dr said that here was no evidence that he had a heart attack or needed to be shocked.

Event Description

Add'l info received on report mw5064311 on 08/29/2016 from reporter: chief complaint: aicd firing and syncope.History of present illness: this is a (b)(6) male with significant past medical history of myocardial infarction and status port aicd placement, chronic kidney failure complaining of 4 episodes of aicd firing and 1 episode of syncope today.Pt was driving his car behind a bus and suddenly he felt a shock by the aicd.He then lost his consciousness about 3 to 4 seconds.Then he hit his car on the bus in front of him.He denies any injury on him and denies any postictal confusion.He denies any chest pain.Denies any shortness of breath.Denies any nausea, vomiting.Denies any fever.Denies any chills.Then he was shocked by his aicd another 3 times after the episode, but denies any further episodes of syncope.His syncope was witnessed by his wife.He had a recent aicd checkup 4 months ago and he has never had any similar episodes in the past and he is compliant with his medications.Physical examination: vital signs: temperature 98, pulse 63, respiration 18, blood pressure is 141 to 169 over 65 to 98, o2 saturation 98% on 2 liters.General: not in acute distress, alert and awake x3.Heent normocephalic.Pupils equal, round, and reactive.Neck: soft, no jvd.No carotid bruit.Cardiovascular: he has an aicd in pocket.No tenderness, erythema around the site.Regular rate and rhythm.No murmurs.No gallops.Distal pulses 2+ bilaterally.Respiration: clear to auscultation.Normal effort.Abdomen: soft, nontender, nondistended.Extremities: no clubbing, no cyanosis.Neurologic: cranial nerves ii-xii intact.Deep tendon reflex 2+.Muscle strength 5/5.Normal sensation.Lab studies: sodium 141, potassium 3.3, bicarb is 24, creatinine is 5.9, bun 25, sugar 132, calcium 9.7, anion gap is 14.Bnp is 343.Wbc 3.6, hemoglobin 12.8.

Event Description

Additional information received from reporter via fax for report # mw5064311 on 09/21/2016.Patient deceased on (b)(6) 2014 from cardiac arrest and a fib.Pacemaker changed (b)(6) 2010 due to premature discharge of battery.

Event Description

Add'l info received on report mw5064311 on 08/29/2016 from reporter: chief complaint: aicd firing and syncope.History of present illness: this is a (b)(6) male with significant past medical history of myocardial infarction and status port aicd placement, chronic kidney failure complaining of 4 episodes of aicd firing and 1 episode of syncope today.Pt was driving his car behind a bus and suddenly he felt a shock by the aicd.He then lost his consciousness about 3 to 4 seconds.Then he hit his car on the bus in front of him.He denies any injury on him and denies any postictal confusion.He denies any chest pain.Denies any shortness of breath.Denies any nausea, vomiting.Denies any fever.Denies any chills.Then he was shocked by his aicd another 3 times after the episode, but denies any further episodes of syncope.His syncope was witnessed by his wife.He had a recent aicd checkup 4 months ago and he has never had any similar episodes in the past and he is compliant with his medications.Physical examination: vital signs: temperature 98, pulse 63, respiration 18, blood pressure is 141 to 169 over 65 to 98, o2 saturation 98% on 2 liters.General: not in acute distress, alert and awake x3.Heent normocephalic.Pupils equal, round, and reactive.Neck: soft, no jvd.No carotid bruit.Cardiovascular: he has an aicd in pocket.No tenderness, erythema around the site.Regular rate and rhythm.No murmurs.No gallops.Distal pulses 2+ bilaterally.Respiration: clear to auscultation.Normal effort.Abdomen: soft, nontender, nondistended.Extremities: no clubbing, no cyanosis.Neurologic: cranial nerves ii-xii intact.Deep tendon reflex 2+.Muscle strength 5/5.Normal sensation.Lab studies: sodium 141, potassium 3.3, bicarb is 24, creatinine is 5.9, bun 25, sugar 132, calcium 9.7, anion gap is 14.Bnp is 343.Wbc 3.6, hemoglobin 12.8.

Event Description

The reporter stated that a relative was given a biotronik pacemaker/defibrillator and there was a 10 year warranty on it but it malfunctioned in 2 years.He had a replacement surgery and that one also malfunctioned and he was driving and ran his car into a bus and the icd was still shocking him.When he arrived at the hospital the dr said that here was no evidence that he had a heart attack or needed to be shocked.

• Brand Name: SETROX S53
• Type of Device: LEADS
• Manufacturer (Section D): BIOTRONIK
• MDR Report Key: 5903369
• MDR Text Key: 53064686
• Report Number: MW5064311
• Device Sequence Number: 2
• Product Code: DTB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2016
• 7 Devices were Involved in the Event: 1 2 3 4 5 6 7

2 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 350974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Death
• Patient Age: 71 YR