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  malfunction  

Event Description

Information was received from multiple sources (family member of patient, healthcare provider, foreign, company representative) regarding a patient who was receiving an unknown drug of an unknown concentration at an unknown dose rate via an implantable pump for unknown indications for use.It was reported that the 400 hotline received a report from a company representative stating that the patient's pump was previously replaced with new due to a motor stall.Refer also to mfr report number 3004209178-2022-03676 regarding prior event/pump motor stall.It was further reported that recently, when adding medicine in the hospital, it was found that the patient's catheter was kinked.The date of the event was not specified/unknown.Drug couldn't be injected into the sheath.The follow-up treatment plan was currently being discussed and confirmed by the doctor.It was noted that effective measures (not specified) had been taken.

Manufacturer Narrative

Concomitant medical products: product id: 8731sc, lot#: 0222172928, implanted: (b)(6) 2021, product type: catheter.Product id: 8731sc, lot#: 0222172928, implanted: (b)(6) 2021, product type: catheter.Other relevant device(s) are: product id: 8731sc, serial/lot #: (b)(4), ubd: 11-mar-2023, udi#: (b)(4).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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a foreign healthcare provider.It was reported that the event / catheter kink was regarding an alternate patient (different device) and there was no catheter problem regarding this patient.Any further information received will continue to be reported in mfr report # 2182207-2022-00814 regarding the correct patient/device.This report (mfr report # 2182207-2022-00766) is considered inactive.

Manufacturer Narrative

H10: regarding additional information received it was determined that the event is regarding an alternate patient (duplicate of event reported previously in mfr report # 2182207-2022-00814).This report (mfr report # 2182207-2022-00766) is now considered inactive and any further information received regarding the event will be reported in mfr report # 2182207-2022-00814.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 14340614
• MDR Text Key: 298399838
• Report Number: 2182207-2022-00766
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

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?: No
• Initial Date Manufacturer Received: 05/07/2022
• Initial Date FDA Received: 05/09/2022
• Supplement Dates Manufacturer Received: 05/16/2022
• Supplement Dates FDA Received: 05/19/2022
• 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 Age: 49 YR
• Patient Sex: Male