MAUDE Adverse Event Report: MEDTRONIC XOMED, INC PROSTHESIS 1156603 PLAT/TI .5MMX4.5MM; REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

Model Number 1156603

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

It was reported that the patient suffered what appeared to be ¿loose wire¿ syndrome, where the patient experiences "blown speaker" distortion, because the crimp on the prosthesis became loose following surgery.On this particular patient, he re-crimped the patient¿s prosthesis, but it did not correct the problem.The doctor completed ¿a first revision and the incus and positioning of the pros theses appeared normal,¿ but the as this did not correct the issue, the patient will return for a second revision and replacement of the product.

Manufacturer Narrative

(b)(4).The product analysis has not been completed at this time.Method: no testing methods performed.Results: results pending completion of evaluation.

Manufacturer Narrative

The product analysis found that there was evidence of biological contaminants (based off of the reactivity with hydrogen peroxide).There were no non-conformities which would have resulted in the reported malfunction when examined by (b)(6) (surgeon).Additionally, the incoming qa records indicate that every lot of platinum wire dating back to (b)(6) 2012 have passed all inspections and there have been no recent changes to the manufacturing process.Method: actual device evaluated.(b)(4).Method: visual inspection; method: labeling.Results: no failure detected.(b)(4).Conclusion: no failure detected, device operated within specification.(b)(4).(b)(4).

Manufacturer Narrative

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

• Brand Name: PROSTHESIS 1156603 PLAT/TI .5MMX4.5MM
• Type of Device: REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
• Manufacturer (Section D): MEDTRONIC XOMED, INC; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: amy corrales ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328138
• MDR Report Key: 4274158
• MDR Text Key: 5295416
• Report Number: 1045254-2014-00302
• Device Sequence Number: 1
• Product Code: ETA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002897
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1156603
• Device Catalogue Number: 1156603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 00034 YR