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

Model Number 8637-40

Device Problem Ambient Temperature Problem (2878)

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

Event Date 05/25/2021

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 patient who was receiving unknown drug via an implantable pump for spinal pain.It was reported that in the seven months the patient has had the pump, "the titration hasn't worked well", and the patient stated they were currently in the hospital because "the pain is horrific." the patient stated their managing hcp told them, "i think you're at the surgical point option but it's not something i do." the patient stated there was a surgeon closer to them who may help but they were doing various scans for the patient to have their "entire spine surveyed." the patient stated they had a cat scan which was fine, but yesterday ((b)(6) 2021) the patient had an mri (magnetic resonance imaging procedure) where the patient had an active scan for only four minutes before they stopped to tell patient the pump was heating up, despite the patient not feeling heating.

Event Description

The patient was receiving bupivacaine, baclofen and dilaudid.

Manufacturer Narrative

B5 has been corrected to provide the drugs being delivered by the pump at the time of the event.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.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
• MDR Report Key: 12044571
• MDR Text Key: 263458608
• Report Number: 3004209178-2021-09770
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2021
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR