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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI ATTAIN STARFIX; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

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MPRI ATTAIN STARFIX; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE Back to Search Results
Model Number 419588
Device Problem Difficult to Remove (1528)
Patient Problems Renal Failure (2041); Cardiac Tamponade (2226); Cardiac Perforation (2513); Multiple Organ Failure (3261)
Event Date 06/20/2014
Event Type  Death  
Manufacturer Narrative
The lead has been returned to the manufacturer and analysis is pending.
 
Manufacturer Narrative
Product event summary: the full lead was returned in segments, analyzed and no anomalies were found.Visual summary analysis of the lead indicated apparent explant damage and visual summary analysis of the lead indicated stretching.
 
Event Description
It was reported the patient, who was enrolled in the starfix 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is reported to have had multisystem organ failure and, after consultation with the family, further treatment was withdrawn and the patient passed away eleven days after system removal.
 
Manufacturer Narrative
This event occurred outside the us where the same model is distributed.All information provided is included in this report.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 medical products: 694765 lead, implanted: (b)(6) 2010; c174awk icd, implanted: (b)(6) 2010.(b)(4).
 
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 baloon pump inserted to aid in hemodynamic stability.The study adjudicated the death as related to the lead, extraction procedure and extraction tool.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
ATTAIN STARFIX
Type of Device
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
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 Key3936238
MDR Text Key11946576
Report Number2649622-2014-07647
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P060039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative,company represent
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,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? Yes
Device Operator Lay User/Patient
Device Expiration Date05/01/2011
Device Model Number419588
Device Catalogue Number419588
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/29/2014
Initial Date FDA Received07/15/2014
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
10/29/2014
Supplement Dates FDA Received08/14/2014
08/28/2014
11/26/2014
09/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/27/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
4076-58 LEAD
Patient Outcome(s) Death;
Patient Age00079 YR
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