MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ALGOLINE; CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM

Model Number 81102

Device Problem Material Integrity Problem (2978)

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

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider via a clinical study on 2018-apr-19 regarding a patient receiving baclofen (dose and concentration unknown) via a temporary intrathecal catheter.The indication for use was unknown.It was reported that the temporary intrathecal catheter was placed on (b)(6) 2018, and a broken catheter was identified in fluoroscopy on (b)(6) 2018.The break prevented baclofen flow and cerebrospinal fluid (csf) collection.The break was identified on day 3 of the study and on the first day of catheter movement.It was noted that the catheter was used per protocol for baclofen administration via bolus and withdrawal of csf.No drug was being administered at the time of identification of breakage, and daily fluoroscopy was part of the study protocol.No patient symptoms/sequelae were reported, and no serious adverse events (saes) were associated with the catheter break.The catheter was removed and discarded in medical waste, and the patient was withdrawn from the study.It was noted that the event was possibly related to the implant procedure.The event did not result in any of the following: in-patient hospitalization, prolongation of existing hospitalization, emergency room visit, urgent care visit, or an unscheduled clinic or office visit.No actions were taken associated with this event and it was indicated the event resolved without sequelae.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider via a clinical study on (b)(6) 2018.It was reported that the catheter may have been damaged at implant.It was specified that the hcp pulled back on the catheter while the introducer needle was in place.It was noted that the patient was a difficult implant with the temporary catheter due to significant spinal hardware in place.The break occurred while repositioning the catheter for the study.

Manufacturer Narrative

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

• Brand Name: ALGOLINE
• Type of Device: CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7456521
• MDR Text Key: 106704607
• Report Number: 3007566237-2018-01234
• Device Sequence Number: 1
• Product Code: MAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 81102
• Device Catalogue Number: 81102
• Device Lot Number: 0031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2018
• 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 Weight: 86