MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. UNKNOWN MEDTRONIC; BUR, EAR, NOSE AND THROAT

Model Number XOM UNKNOWN

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problems Headache (1880); Device Embedded In Tissue or Plaque (3165)

Event Date 02/26/2014

Event Type  Injury  

Event Description

It was reported that a procedure occurred to remove a metal fragment in the patient¿s nasal septum.Reportedly, the patient had undergone endoscopic endonasal trans-sphenoid surgery of pituitary adenoma on (b)(6) 2010 and on (b)(6) 2011, at the user facility.The patient presented with history of headaches and ventriculoperitoneal shunting.An x-ray and subsequent mri demonstrated the presence a foreign metal fragment approximately 3mm in length in the nasal septum.It is alleged that the removed metal fragment is from a broken bur/blade; however, it is unknown when the fragment occurred.Per the facility, there was nothing noted in any of the prior procedures indicating a broken bur/blade that was left in the patient.It was noted that the patient¿s outcome was good following the procedure to remove the fragment.

Manufacturer Narrative

(b)(4): no devices were returned for evaluation.No testing methods performed.(b)(4).

Manufacturer Narrative

[patient] suffered injuries ¿including, but not limited to, the following: chronic and severe headaches; build-up of cerebro-spinal fluid pressure in her brain necessitating the installation of a drainage shunt; improper functioning of the shunt and further buildup of cerebro-spinal fluid pressure; swelling of the face and eye; a heart attack; physical and emotional pain and suffering." (b)(6).

Event Description

Additional information received: ".[patient] suffered injuries.Including, but not limited to, the following: chronic and severe headaches; build-up of cerebro-spinal fluid pressure in her brain necessitating the installation of a drainage shunt; improper functioning of the shunt and further buildup of cerebro-spinal fluid pressure; swelling of the face and eye; a heart attack; physical and emotional pain and suffering".

Manufacturer Narrative

Additional information in the form of medical and operative notes detailing the following: (b)(6) 2010: (1)endoscopic transnasal transsphenoidal approach for resection of pituitary adenoma, primary surgeon dr.(b)(6); (2) endoscopic resection of pituitary macroadenoma, primary surgeon dr (b)(6).It is noted that there was never any csf fluid visualized during procedure.Operative notes indicate no complications and all counts correct.No adverse events noted in operative report.(b)(6) 2011: (1) transsphenoidal resection of pituitary microadenoma assisted by frameless stereotactic navigation, primary surgeon dr (b)(6); (2) revision endoscopic transsphenoidal approach for excision of pituitary adenoma, primary surgeon dr (b)(6).(3) microsurgical resection of tumor was performed by dr (b)(6).Operative notes indicate no complications and all counts correct.No adverse events noted in operative report.(b)(6) 2011: diagnostic radiology (skull ltd <(><<)> 4 views) abdominal pain and headache status post vp shunt placement on (b)(6) 2011.Findings: incidental note is made of a small radiodensity in the midline, adjacent to the posterior walls of the maxillary sinuses, and presumably in the nares.This finding appears to been present on the scout topogram of the head ct dated (b)(6) 2011.(b)(6) 2013: x-ray radiology examination of sinuses (4 views) compared to (b)(6) 2008.Findings: the paranasal sinuses are clear.There are no osseous lesions.Partially visualized is a vp shunt entering through the right cranium.(b)(6) 2013: x-ray radiology examination of sinuses compared to (b)(6) 2013.Caldwell, waters, and lateral views; submental vertex view of paranasal sinuses.Findings: portions of vp shunt catheter are visualized directed from the right side.At this time, there is no evidence of acute or chronic sinusitis.A radiodense foreign body is seen in the posterior midline aspect of the nasal cavity.This is unchanged from the previous exam.(b)(6) 2014: x-ray radiology examination (2 views of skull); findings: a small radiopaque device projects over the nasal septum.No additional radiopaque devices are appreciated.(b)(6) 2014: mri (brain with and w/o contrast) compared to ct brain (b)(6) 2013.Impression: a right ventricular peritoneal shunt with its tip in the left lateral ventricle frontal horn is noted.The ventricle size is normal.There is slight irregularity along the diaphragmatic sella but no focal hypo-hyperintense lesion or abnormal enhancement seen.(b)(6) 2014: procedure for endoscopic removal of nasal foreign body, endoscopic release left nasal synechia, right nasal endoscopy.It was noted in the operative report that there was a mucosally covered metallic foreign body, at the level of the posterior septum, that was easily removed without complications.Surgeon was dr (b)(6).(b)(6) 2014: surgery pathology report.Metallic foreign body, ¿consists of a 0.6 x 0.4 x 0.3 cm irregularly shaped fragment of silver metallic material.One surface exhibits multiple distorted teeth-like projections.No inscriptions are identified.No soft tissue is identified.(b)(6) 2014: post-operative follow-up notes state ¿the foreign body was confirmed to be the tip of the meditech microdebrider.She admits to some discomfort over the surgical site since this procedure.Patient medical history: acromegaly; pseudo tumor cerebri; myocardial infarction (b)(6) 2012 s/p placement of a single cardiac stent.Tobacco history: currently smoking.

Manufacturer Narrative

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

• Brand Name: UNKNOWN MEDTRONIC
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC, INC.; 6473 southpoint dr north; jacksonville FL 32216
• Manufacturer Contact: charlotte ayala ; 6473 southpoint dr north; jacksonville, FL 32216 ; 9043328372
• MDR Report Key: 3675577
• MDR Text Key: 4299910
• Report Number: 1045254-2014-00057
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/26/2014

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: Health Professional
• Device Model Number: XOM UNKNOWN
• Device Catalogue Number: XOM UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/26/2015
• Initial Date FDA Received: 03/12/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 06/26/2015
• Supplement Dates FDA Received: 02/10/2015; 07/16/2015; 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 00038 YR
• Patient Weight: 73