MAUDE Adverse Event Report: RICE CREEK MFG TWO IS-1 UNI LEADS TO IS-1 BI IPG ADAPTOR KIT; ADAPTOR, LEAD, PACEMAKER

Model Number 586638M

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2014

Event Type  Injury  

Event Description

It was reported that the right ventricular lead adapter was returned to the manufacturer, analyzed, and tested out of specification.No patient complications have been reported as a result of this event.

Manufacturer Narrative

This report is based solely on device analysis.No information to suggest a device related adverse event or product problem was received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: 586638m distal conductor of the lead developed a fracture due to flexing while in vivo.Concomitant products: p1501dr ipg, implanted: (b)(6) 2010; a 5071-53 lead, serial number: (b)(4), implanted: (b)(6) 2006; a 5071-53 lead, serial number: (b)(4), implanted: (b)(6) 2006; a 5856-38m lead adaptor, implanted: (b)(6) 2006.(b)(4).

• Brand Name: TWO IS-1 UNI LEADS TO IS-1 BI IPG ADAPTOR KIT
• Type of Device: ADAPTOR, LEAD, PACEMAKER
• Manufacturer (Section D): RICE CREEK MFG; 7000 central ave ne; fridley MN 55432
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4159293
• MDR Text Key: 16859099
• Report Number: 6000030-2014-00139
• Device Sequence Number: 1
• Product Code: DTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 586638M
• Device Catalogue Number: 586638M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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: 4951M-53 LEAD ADAPTOR
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00052 YR