MAUDE Adverse Event Report: MPRI STYLET KIT; STYLET, CATHETER

Model Number 6094-45

Device Problem Device Expiration Issue (1216)

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

Event Date 02/17/2014

Event Type  malfunction  

Event Description

It was reported that the right ventricular (rv) lead dislodged when the patient raised their arms.The lead was repositioned and remains in use.A stylet kit that was past the expiration date was used during the procedure.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Concomitant product: 5076 (x2) implantable pacing lead, (b)(6) 2014.(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: STYLET KIT
• Type of Device: STYLET, CATHETER
• 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 Key: 3742546
• MDR Text Key: 4221892
• Report Number: 2649622-2014-03848
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2014
• Device Model Number: 6094-45
• Device Catalogue Number: 6094-45
• Device Lot Number: V397512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2014
• Date Device Manufactured: 05/12/2010
• 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: ADDR01 IMPLANTABLE PULSE GENERATOR
• Patient Age: 00075 YR