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

Model Number NEU_UNKNOWN_PUMP

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8731sc, lot #: unknown, implanted: (b)(6) 2020, product type: catheter. Other relevant device(s) are: serial/lot #: unknown. If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who was receiving an unknown drug of an unknown concentration at an unknown dose rate via an implantable pump. It was reported that the patient previously had their pump replaced due to a motor stall. Refer also to mfr report # 2182207-2022-00456 regarding prior event/stall. Recently, the patient's catheter was found to be crooked (kinked) when adding medicine in the hospital. As a result, the drug could not be injected into the sheath. The catheter was replaced with new. There wasn¿t any influence on the normal treatment currently.

• 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: 14430872
• MDR Text Key: 291960801
• Report Number: 2182207-2022-00814
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• 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: 05/18/2022 Patient Sequence Number: 1