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

Model Number 8637-40

Device Problems Device Alarm System (1012); Filling Problem (1233); Improper or Incorrect Procedure or Method (2017); Insufficient Flow or Under Infusion (2182)

Patient Problems Pain (1994); Seroma (2069)

Event Date 05/01/2020

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 currently receiving gablofen at 99 mcg/day via an implanted pump.Per the patient¿s caregiver, the pump was implanted due to an injury that resulted in the patient being paralyzed from the waist down.It was reported by the patient¿s caregiver that earlier this year the patient went in for a pump refill and the hcp (healthcare professional) had difficulty filling the pump.They told the patient it was due to the pump being tipped in the patient¿s body.The patient was referred to 3 doctors to refill the pump and the third doctor told them he withdrew the medication and refilled the pump.A week after the refill, the patient began to experience pain on that side were the pump sat.The patient then went in for a refill a week and a half ago wednesday and it was discovered that the pump was empty.The reporter stated that they have no idea how long the pump had been empty.They used the tablet to active the alarm and the hcp had to use a stethoscope to hear the alarm.They did a cat scan with dye which determined that everything with the pump and catheter was fine.At the refill a week and a half ago, they had difficulty accessing the pump and after 45 minutes the patient was referred to another doctor who refilled the pump by ultrasound.Following the refill, the patient felt better, but had a severe reaction to the baclofen.Per the reporter, over the course of the 2 years of having the pump, the dose was increased from 100 mcg/day to 124 mcg/day but due the severe reaction, the medication was turned down to 99 mcg/day.The patient was currently hospitalized due to experiencing severe back pain and leg pain that had been present for a week now.The patient was awake and more cognizant now.She was eating again and wasn¿t in so much pain.Per the reporter, over the last 2 years, the patient had gained weight due to lack of movement and had more weight in the area of the pump than when it was implanted.The hcp did an ultrasound yesterday and found several ¿pockets of liquid around the pump¿ and the doctor thought that at the refill 5 months ago the medication didn¿t make it into the patient¿s pump and the pockets of liquid were the residual baclofen from that refill.The reporter was calling because he wanted to get advice as far as what to do.The patient was redirected to their hcp to discuss.

Manufacturer Narrative

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 the patient who reported that no action was taken to resolve the pockets of liquid around the pump because the doctors didn¿t feel it was necessary to remove the fluid.

• 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: 10648490
• MDR Text Key: 210493187
• Report Number: 3004209178-2020-17509
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: 10/26/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 116