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

Model Number 4196

Device Problems Break (1069); Fracture (1260)

Patient Problem Occlusion (1984)

Event Date 01/03/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: dtba1d1 crt-d, implanted (b)(6) 2014; 4024-45 lead, implanted: (b)(6) 2000.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the right atrial (ra) lead had fractured.The lead was capped and replaced.During the replacement procedure, the left ventricular (lv) lead was noted to be grossly fractured, more specifically severed.The lv lead was partially explanted and replaced.The right ventricular (rv) lead was sacrificed to obtain venous access in the patient who was completely occluded.During rv lead extraction, the physician was unable to place a stylet more than ten centimeters into the lead.The lead reportedly fractured and eventually became unraveled.The lead was partially removed and replaced.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the right atrial (ra) lead had fractured.The patient reportedly experienced decreased ventricular function due to loss of atrial support.The lead was capped and replaced.During the replacement procedure, the left ventricular (lv) lead was noted to be grossly fractured, more specifically severed.The lv lead was partially explanted and replaced.The right ventricular (rv) lead was sacrificed to obtain venous access in the patient who was completely occluded.During rv lead extraction, the physician was unable to place a stylet more than ten centimeters into the lead.The lead reportedly fractured and eventually became unraveled.The lead was partially removed and replaced.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN ABILITY MRI SURESCAN
• 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): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9613169
• MDR Text Key: 175858302
• Report Number: 2649622-2020-01635
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

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 Date: 08/24/2009
• Device Model Number: 4196
• Device Catalogue Number: 4196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2020
• Initial Date FDA Received: 01/21/2020
• Supplement Dates Manufacturer Received: 01/21/2020
• Supplement Dates FDA Received: 01/21/2020
• Date Device Manufactured: 02/24/2009
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 23 YR
• Patient Weight: 54