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

Model Number C174AWK

Device Problems Nonstandard Device (1420); Difficult to Remove (1528)

Patient Problems Death (1802); Endocarditis (1834); Fever (1858); Low Blood Pressure/ Hypotension (1914); Laceration(s) (1946); Renal Failure (2041); Sepsis (2067); Swelling (2091); Multiple Organ Failure (3261)

Event Date 06/20/2014

Event Type  Death  

Event Description

It was reported the patient, who was enrolled in the (b)(6) clinical study, is deceased.The patient presented to the hospital with a one month history of fevers.The device site was found to be swollen and blood cultures were taken and were consistent with enterococcus faecalis septicemia.The patient¿s urine cultures were noted to have grown klebsiella and the patient was noted to have endocarditis.An echocardiogram was performed and noted large vegetation on the tricuspid valve.The patient underwent surgery to remove the device system.The device, right atrial and right ventricle were removed without difficulty.The left ventricular (lv) lead was unable to be removed with traction and a laser sheath was passed over the lead and the lead was removed with difficulty.After removal of the lv lead the patient became hypotensive and the patient was found to have a myocardial laceration and pericardial tamponade.A chest tube was placed and an intraaortic balloon pump was placed.Two epicardial leads were placed and connected to a dual-chamber pacemaker.The patient was taken to the intensive care unit and was treated with antibiotics, inotropes and pressers.The patient developed renal failure requiring dialysis and the sepsis persisted.The patient is reported to have had multisystem organ failure and, after consultation with the family, further treatment was withdrawn and the patient passed away eleven days after system removal.

Event Description

Additional information received reported the patient's blood pressure decreased intraoperative and a pericardial tamponade was suspected.A limited sternotomy was performed and blood was found in the pericardial cavity.The blood was evacuated and the blood pressure stabilized.Upon examination, a tear was observed in the coronary sinus.The tear was sutured and pericardial drains were placed to control the bleeding.An epicardial pacing system was placed and an intra-aortic balloon pump inserted to aid in hemodynamic stability.The study adjudicated the death as related to the lead, extraction procedure and extraction tool.

Manufacturer Narrative

Product event summary:the device was returned and analyzed.Analysis was performed and no anomalies were found.

Manufacturer Narrative

This model number is not approved for distribution in the united states; however, it is same/similar to a device marketed in the u.S.This event occurred outside the us and patient information is not generally available due to confidentiality concerns.The initial reported event was received on (b)(6) 2014.Of note, the serious injury of sepsis is normally submitted via a bimonthly medwatch report submission that would have been due on (b)(6) 2014.Information was subsequently received on (b)(6) 2014 and revealed the patient is deceased.As there is new information that reasonably suggests the device has or may have caused or contributed to a death, this event no longer qualifies for bimonthly reporting and is therefore being submitted as a 30-day report.Concomitant products: 419588 lead, implanted: (b)(6) 2010; 694765 lead, implanted: (b)(6) 2010.(b)(4).

• Brand Name: CONCERTO
• 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: 3936275
• MDR Text Key: 4574391
• Report Number: 9614453-2014-01543
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2014

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/14/2011
• Device Model Number: C174AWK
• Device Catalogue Number: C174AWK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2014
• Initial Date FDA Received: 07/15/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/12/2014; 11/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2009
• 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
• Treatment: 4076-58 LEAD
• Patient Outcome(s): Death
• Patient Age: 00079 YR