MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient receiving morphine (3 mg/ml at 1.2001 mg/day) via an implanted pump.The indication for pump use was spinal pain.The patient reported that she had issues since january of this year.She clarified that she had upper left quadrant pain in her abdomen.She stated that she had a lot of scans done to try and determine the cause of the pain.Today she had a ¿cta¿ performed which showed ¿a wire or something coming out from the pump around to the back and it¿s not connected to anything¿.She stated, ¿they know the catheter is still there in my back but are unsure of what the wire is¿.The patient was planning to follow-up with her healthcare provider.

Event Description

On 2021-(b)(6), additional information was received from the patient.They reported they spoke with their pain management healthcare professional (hcp) who told the patient they don¿t see anything wrong with results from cta and stated the "radiologist is reading it wrong".The patient stated they then got an x-ray that "go further into about what's wrong with the fractured stimulator".The patient stated that prior to the pump, they had a stimulator implanted (non-mdt, unknown manufacturer) and "now there's a broken stimulator lead showing up in testing".The patient read an excerpt from a report, "there is a separate fragment unattached to the device that goes from t11 to l4".The patient stated there should be nothing below l1.The patient mentioned their pain was getting worse and worse in their back.The patient wanted a second opinion but had been unable to obtain one.Further troubleshooting could not be performed as the call was disconnected.***this event is no longer a reportable event.Mdr decision updated to not reportable.No additional supplemental mdrs are required unless additional information received makes the event reportable.***.

Manufacturer Narrative

H6 codes updated to reflect new information 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 II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12819603
• MDR Text Key: 280813723
• Report Number: 3004209178-2021-17077
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• 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,Followup
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2021
• Date Device Manufactured: 12/11/2018
• 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 Age: 54 YR
• Patient Sex: Female