MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number NEU_UNKNOWN_PUMP

Device Problems Difficult or Delayed Positioning (1157); Difficult to Advance (2920)

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

Event Date 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

The main component of the device system; the other relevant components include: product id: 8780, serial#: (b)(4), product type: catheter.Analysis results were not available at the time of this report.A follow up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer's representative (rep) regarding a patient who was receiving 500 mcg/ml lioresal at 50 mcg/day via an implantable infusion pump for an unknown indication for use.It was reported that when the doctor was putting in a baclofen pump, the needle was placed and cerebrospinal fluid was received, but when the hcp tried to advance the catheter the catheter went toward the patient's feet instead of towards their head.The hcp took the needle and catheter out because of it going in the wrong direction.The hcp then stated the end of the catheter felt more pliable than usual.The hcp did not feel as though the stylet was advanced enough to the tip of the catheter.A different catheter was used instead.It was reported that the issue was resolved at the time of the report.The patient's status at the time of the report was noted as "alive-no injury." no further complications were anticipated/reported.On 2018-02-26 rp, (rep): no new information was contained in the document.

Manufacturer Narrative

Analysis found that there was damage to the guidewire.Product id: 8780, serial# (b)(4), product type: catheter.If information is provided in the future, a supplemental report will be issued.

• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• 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: 7307324
• MDR Text Key: 101582594
• Report Number: 3007566237-2018-00613
• Device Sequence Number: 1
• Product Code: LKK
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2018

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: NEU_UNKNOWN_PUMP
• Device Catalogue Number: NEU_UNKNOWN_PUMP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/26/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2018
• Initial Date FDA Received: 03/01/2018
• Supplement Dates Manufacturer Received: 04/17/2018
• Supplement Dates FDA Received: 04/24/2018
• 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