MAUDE Adverse Event Report: GIVEN IMAGING LOS ANGELES LLC PISCES Z QUAD; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 3890

Device Problem Difficult to Remove (1528)

Patient Problems Sedation (2368); Radiation Exposure, Unintended (3164)

Event Date 10/25/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, the patient had been intubated and after the study was completed, the catheter would not remove nor come out of the patient¿s nose, allowing the patient to remain intubated.The patient was sent to radiology and they performed x-rays and it showed the probe was stuck in the patient's nose on a bone ¿ nostril.The patient was then sent to emergency room where the patient had to be sedated to remove the catheter.The catheter was removed, and the patient has been sent home.The catheter worked correctly during the previous procedure.

Manufacturer Narrative

H3 evaluation summary: this report is based on information provided by investigation personnel.The customer reported that the catheter is damaged, probe was stuck in patients nose.One device was received for evaluation.The visual inspection found the silicone sleeve is damaged.The lap tube is bunching at the strain relief carrier.The returned sample did not meet specification as received.The investigation found the catheter calibrated but failed in thermal test.All impedance sensors have signal and are functional in saline solution.The pico scope data shows all sensors are responding.The investigation found the most probable cause to be the silicone sleeve damage.The probable root cause was found to be user mishandling.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: PISCES Z QUAD
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): GIVEN IMAGING LOS ANGELES LLC; 5860 uplander way; culver city CA 90230
• MDR Report Key: 9306992
• MDR Text Key: 166519436
• Report Number: 3005344223-2019-00016
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 04260167482446
• UDI-Public: 04260167482446
• Combination Product (y/n): N
• PMA/PMN Number: K151086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

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: 3890
• Device Catalogue Number: 3890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Initial Date Manufacturer Received: 10/25/2019
• Initial Date FDA Received: 11/11/2019
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR