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

Model Number 8637-40

Device Problems Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Unstable (1667); Device Displays Incorrect Message (2591); Ambient Temperature Problem (2878); Communication or Transmission Problem (2896); Temperature Problem (3022)

Patient Problems Erythema (1840); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Malaise (2359)

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

Additional information received on 2018-mar-28 provided context to link previously unreported information from the consumer's initial report to the previously submitted malfunction.Possible correlation between this information and the malfunction warranted inclusion.Information provided was originally contained in the initial report, received on 2018-mar-26.The main component of the system and other applicable components are: product id 8840,serial# unknown, product type: programmer, physician.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on (b)(6) 2018, the patient had an mri and the pump got really hot.The reason for the mri was a separate issue/not related to the pump or therapy.It was for his back.On (b)(6) 2018, the patient had surgery on his belly and since then the pump felt a little bit tighter.The patient did not know if the surgery was related to the pump.The surgery was done on a spot close to the area where the pump was.There were no further complications reported at this time.It was reported that the physician programmer was not reading the patient's pump the programmer was saying invalid telemetry.No symptoms were reported.There were no further complications reported at this time.Additional information was received from the consumer.The patient reported there was no telemetry on the pump.Additional information was received from a consumer.It was reported that the pump was "not working (pump is turned off)." the patient was not getting any pain relief, was hurting bad, and felt like crap and was miserable.He had spoken with his healthcare provider (hcp) about his increased pain levels and they did not want to turn up the medication.The hcp did a fluoroscopy and the pump appeared to have flipped.The patient was feeling a lot of pain where the pump was and there was redness.It was getting worse and worse.Last week (from (b)(6)2018), the patient felt like he was going through withdrawals, but was not sure what was going on because they were not severe symptoms.The patient would follow up with their hcp to discuss symptoms.His implanted hcp could not see him until next week (from (b)(6) 2018).The pump was hurting the patient and he was on his way to the hospital.He was going to see if they could take the pump out because he did not want to sit around and wait until next week.The way he was feeling was not pleasant.When the pump was working it was excellent.After his panniculectomy surgery, the doctor put him on an oral pain medication and after he was done taking that was when he noticed he was not getting any pain relief.The surgery was on (b)(6) 2018 on the bottom of his abdomen.They had to pull the skin down tight to close the incision.They removed tumors he had in his belly.There were no further complications reported at this time.

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 who was receiving fentanyl (40% solution at 20mcg/day) via intrathecal drug delivery pump.The indication for use was noted as spinal pain.It was reported that starting in (b)(6) 2018 or (b)(6) 2018, the patient's pain levels had been exacerbated a little bit, but he just figured that was normal.The patient clarified he had an increase in pain.It had worsened over time.There were no further complications reported at this time.Additional information was received from a consumer.It was reported the pump was not working and appeared to have flipped.

Manufacturer Narrative

Concomitant medical products: product id: 8870, serial# unknown, product type: software.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: 7385716
• MDR Text Key: 104088355
• Report Number: 3004209178-2018-06124
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR