MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO, INC. SPRINT FIDELIS IMPLANTABLE TACHY LEAD

Model Number 6949

Device Problems Failure to Capture (1081); Fracture (1260); High impedance (1291); Over-Sensing (1438)

Patient Problem Death (1802)

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.

• Brand Name: SPRINT FIDELIS
• Type of Device: IMPLANTABLE 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 Key: 2052296
• MDR Text Key: 1865685
• Report Number: 2649622-2011-07132
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: P920015/S029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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 Received: 04/12/2011
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: LAY USER/PATIENT
• Device MODEL Number: 6949
• Device Catalogue Number: ASKU
• Device LOT Number: ASKU
• OTHER Device ID Number: ASKU
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: No
• Device Age: 4 yr
• Event Location: Hospital
• Date Manufacturer Received: 02/06/2011
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 01/22/2007
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-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