MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION TEMPORARY BIPOLAR MYOCARDIAL PACING LEAD; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 6495

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 07/01/2014

Event Type  Injury  

Event Description

Medtronic received information that a temporary pacing lead had dislodged during use.No additional information was provided.Additional information has been requested.

Manufacturer Narrative

A supplemental report will be filed if additional information is received or when the investigation is completed.A review of medtronic's databases did not indicate that a separate report exists for this event.(b)(4).

Manufacturer Narrative

Additional information was received that temporary pacing wire was pulled out of the heart when the surgeon was pulling it through the skin.There was no malfunction of the device.Additional information has been requested.A supplemental report will be filed if additional information is received or when the investigation is completed.

Manufacturer Narrative

Additional information was received that this event occurred during surgery, and a replacement wire was placed.There were no adverse patient effects as a result of the temporary pacing wire being pulled out.This event was erroneously reported as a serious injury.There was no serious injury or product malfunction.

Manufacturer Narrative

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

• Brand Name: TEMPORARY BIPOLAR MYOCARDIAL PACING LEAD
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 east deere ave.; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 3961791
• MDR Text Key: 4557833
• Report Number: 2025587-2014-00526
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6495
• Device Catalogue Number: 6495
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2014
• Initial Date FDA Received: 07/28/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 08/18/2014
• Supplement Dates FDA Received: 08/18/2014; 08/18/2014; 09/14/2017
• Was Device Evaluated by Manufacturer?: No
• 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