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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO, INC. SPRINT FIDELIS IMPLANTABLE TACHY LEAD
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MEDTRONIC PUERTO RICO, INC. SPRINT FIDELIS IMPLANTABLE TACHY LEAD Back to Search Results
Model Number 6949
Device Problems Failure to Capture; Fracture; High impedance; Over-Sensing
Event Type  Death  
Event Description

Asku.

 
Event Description

It was reported that the lead fractured and the lead integrity alert triggered. It was further reported that the patient's heart rhythm was asystolic and the patient was very symptomatic. Additionally, it was reported that the lead was oversensing, had no capture and had high impedance. The lead was capped and replaced. Further information received indicated the patient subsequently died one day after the lead was capped due to congestive heart failure, electromechanical disassociation and cardiac arrest.

 
Manufacturer Narrative

The initial reported event was received on (b)(6) 2011. Of note, the reportable malfunction and/or serious injury of lead fracture, oversensing, no capture and high impedance is normally submitted via a remedial action exemption report that would have been submitted (b)(6) 2011. Information was subsequently received on (b)(6) 2011 and revealed the patient died. As there is new information that reasonably suggests the device has or may have caused or contributed to a patient death, this event no longer qualifies for remedial action exemption reporting and is therefore being submitted as a 30-day report. The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted. This event is one of two reports associated with the death of this patient. Reference report numbers: 2649622000-2011-07148, 2647346000-2011-00543, 2649622000-2011-07149. Evaluation summary: (b)(4) the full lead was returned, analyzed and the proximal conductor was fractured. It was noted that the distal and defibrillation coil conductor were distorted, there was blood/body fluid on the distal conductor (not obstructed), there was a fracture of the defibrillation conductor, outer tubing was kinked/buckled, outer insulation was melted, outer tubing overlay was melted and had environmental stress cracking, outer tubing overlay had an environmental stress cracking breach/breach (non-electrical), outer insulation was breached cut, there was a white substance on the exposed defibrillation coil/ outer overlay tubing/tip electrode, the outer insulation had a cosmetic depression and the lead was stretched.

 
Manufacturer Narrative

The initial reported event was received on (b)(4) 2011. Of note, the reportable malfunction and/or serious injury of lead fracture, oversensing, no capture and high impedance is normally submitted via a remedial action exemption report that would have been submitted (b)(6) 2011. Information was subsequently received on (b)(4) 2011 and revealed the patient died. As there is new information that reasonably suggests the device has or may have caused or contributed to a patient death, this event no longer qualifies for remedial action exemption reporting and is therefore being submitted as a 30-day report. The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted. This event is one of two reports associated with the death of this patient. Reference report numbers: 2649622000-2011-07148, 2647346000-2011-00543, 2649622000-2011-07149. Analysis of the device is in process; the results will be forwarded when available.

 
Manufacturer Narrative

The initial reported event was received on (b)(6) 2011. Of note, the reportable malfunction and/or serious injury of lead fracture, oversensing, no capture and high impedance is normally submitted via a remedial action exemption report that would have been submitted (b)(6) 2011. Information was subsequently received on (b)(6) 2011 and revealed the patient died. As there is new information that reasonably suggests the device has or may have caused or contributed to a patient death, this event no longer qualifies for remedial action exemption reporting and is therefore, being submitted as a 30-day report. The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted. This event is one of two reports associated with the death of this patient. Analysis of the device is in process; the results will be forwarded when available.

 
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Brand NameSPRINT FIDELIS
Type of DeviceIMPLANTABLE TACHY LEAD
Manufacturer (Section D)
MEDTRONIC PUERTO RICO, INC.
road 149
km 56.3, box 6001
villalba PR 00766
Manufacturer Contact
chad hedlund sr vigilance compliance mgr
cardiac rhythm disease mgmt
8200 coral sea st. n.e.
mounds view , MN 55112
7635149619
MDR Report Key2052296
Report Number2649622-2011-07132
Device Sequence Number1
Product CodeLWS
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Remedial Action Recall
Type of Report Initial,Followup,Followup
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/12/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number6949
Device Catalogue NumberASKU
Device LOT NumberASKU
OTHER Device ID NumberASKU
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Device Age4 yr
Event Location Hospital
Date Manufacturer Received02/06/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/22/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0070-2008

Patient TREATMENT DATA
Date Received: 04/12/2011 Patient Sequence Number: 1
Treatment
4076 IMPLANTABLE PACING LEAD
4076 IMPLANTABLE PACING LEAD
A7700 MECHANICAL HEART VALVE
(B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB
A7700 MECHANICAL HEART VALVE
(B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB
(B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB
4076 IMPLANTABLE PACING LEAD
A7700 MECHANICAL HEART VALVE
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