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

Model Number 8617L-18

Device Problem Disconnection (1171)

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

Event Type  Injury  

Event Description

Information was received from a consumer (con) regarding patient receiving unknown drug.The indication use was unknown.The patient reported a lot of problems with the device.They changed the location of the catheter.The patient got complete block on their spine so the doctor that put it in was not a very good doctor, and he did not look at the x-rays beforeand after the implant.The doctor asked me a week or two later about how i felt and i said, ¿i don't feel any different.¿ the patient asked if he did not put it above or below the block and then he said we had to do surgery again.So, he changed it and did not do good at that because they had a follow up with him and felt good the first day but then it went away.So, he dismissed me as a patient who's case was out of hand and that this was my fault.What happened was where he spliced the catheter came apart, so the patient was not getting any medication from the pump and lost spinal fluid.It happened at least twice.So, the patient confidence in these devices was lacking.' the patient stated this happened 'in the 90's,' and they think they had morphine in the pump at the time.

Manufacturer Narrative

Continuation of d10: product id 8703 lot# serial# (b)(4) implanted: explanted: product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8703, serial/lot #: (b)(4), ubd: , udi#: 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: SYNCHROMED
• 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: 16770332
• MDR Text Key: 313595538
• Report Number: 2182207-2023-00700
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/04/1998
• Device Model Number: 8617L-18
• Device Catalogue Number: 8617L-18
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2023
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Sex: Male