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

Model Number 8637-20

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Dyspnea (1816); Swelling (2091)

Event Date 05/30/2019

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 currently receiving morphine of an unknown concentration at ¿3%¿ mg/day dose via intrathecal drug delivery pump for non-malignant pain.It was reported that the day after implant patient took a bad fall over the dogs.Patient didn't go to the hospital or anything but the following morning she got up and noticed she was swollen from the waist down.Her right leg was 6'' more swollen/fatter than the left.The date of the event regarding swelling was indicated as being (b)(6) 2019.Patient had seen a healthcare professional (hcp) and they wanted to rule out a blood clot.X-ray confirmed no broken leg/foot.Patient experienced some shortness of breath and saw a cardiologist.The patient had also been sent to a pulmonary physician for symptoms there too.On (b)(6) 2019 the patient was to have her veins in her legs checked.It was noted that the patient wondered if the fall could have impacted the pump.For drug, it was indicated that patient may have been started at 1% previously and may be at 3%.The patient just had her first refill last week.Patient also had a stimulator located near the pump, but no indication was reported that this was a manufacturer device and no allegations were made regarding it.Patient felt the pump move.Patient was sitting on the side of the bed and she felt the pump roll.The date of the event regarding having fell the pump move was described as about a week ago and end of (b)(6) 2019 was confirmed (month and year known only).Patient was not sure if it was sitting on a muscle or something.Patient talked to the hcp and there was certain amount the pump was supposed to move.No further complications were reported.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9135138
• MDR Text Key: 165253584
• Report Number: 3004209178-2019-18641
• 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
• Report Date: 09/30/2019

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: 10/28/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 09/30/2019
• Date Device Manufactured: 05/08/2019
• 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
• Patient Age: 70 YR