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

Model Number NEU_UNKNOWN_PUMP

Device Problems Difficult to Advance (2920); Material Integrity Problem (2978)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/11/2021

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 14-may-2023, udi#: (b)(4), product type: catheter; product id: 8781, serial/lot #: (b)(4), ubd: 28-jun-2023, udi#: (b)(4), product type: catheter. If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from foreign healthcare provider (hcp) via a manufacturer's representative (rep) regarding a patient with an implantable pump. On (b)(6) 2021, it was reported that the patient was having a catheter implanted. It was noted that, because the patient had a lumbar kyphosis, the placement of the catheter was difficult. While trying to manipulate the catheter to advance it along the spinal column, the hcp reported that the catheter broke 1 cm from the extremity of the catheter. The hcp attempted to implant a second catheter but the catheter broke at the same level. In the end, no catheter was implanted, but 2 pieces of catheter (1 cm each) were left in the spinal canal. The patient reportedly would not receive any tdd therapy. The issue was considered resolved. The patient's status was listed as "alive - no injury". Additional information was received from a foreign manufacturer's representative (rep) on 2021-oct-20. It was reported that no pump or catheter were implanted in the patient as the event happened during surgery.

• Brand Name: IMPLANTABLE DRUG INFUSION PUMP
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12694318
• MDR Text Key: 282841577
• Report Number: 2182207-2021-01863
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: NEU_UNKNOWN_PUMP
• Device Catalogue Number: NEU_UNKNOWN_PUMP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2022
• 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 Treatment Data

Date Received: 10/25/2021 Patient Sequence Number: 1