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

Model Number 8637-20

Device Problems Filling Problem (1233); Improper or Incorrect Procedure or Method (2017); Overfill (2404); Infusion or Flow Problem (2964)

Patient Problems Overdose (1988); Pain (1994); Swelling (2091); Complaint, Ill-Defined (2331)

Event Date 12/03/2018

Event Type  Injury  

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 (unknown concentration at 0.18 mg/day) via an implantable infusion pump.The indications for use were noted to be non-malignant pain and radiculopathy.It was reported that the patient had his pump refilled on (b)(6) 2018.He noted his doctor "tried 5 times hitting the hole" when refilling the pump.About 2 hours after the refill the patient felt swelling in the pocket area.He started "feeling the catheter." the area was painful and swollen up.He went back to the doctor's office on (b)(6) 2018 and they "redid the pump: pulled the normal amount of medicine" and refilled the pump.The doctor said the pump was working fine.On (b)(6) 2018 the patient went to the emergency room because "he was overdosed." the patient did not take any other medications.The patient was calling to get physician listings to take the pump out because he did "not want to be overdosed/overfilled again." no further complications were reported.

Manufacturer Narrative

Product id: 8780, serial# (b)(4), implanted: (b)(6) 2015, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer.It was reported that the patient had been "in agony" since the pump was refilled on (b)(6) 2018 (note this contradicts the previously reported refill date of (b)(6) 2018).He felt pain and swelling where the catheter entered his spine to the "center bottom of the pump itself." he also noted that the refill was painful when the physician's assistant had to "stick him 4 times." he went back to the doctor's office on (b)(6) 2018 and the doctor removed the medication from the pump but he "had more drug than he should have." his pain in his back had not gone away and was like it was prior to the pump implant.He went back to the doctor's office again on (b)(6) 2018, where the doctor removed and replaced the medication as the doctor thought "it was bad medication" but the patient did not get any pain relief after that was done.The doctor had scheduled a dye study to examine the catheter for (b)(6) 2019.No further complications were reported.Additional information was received from a consumer.It was reported that a dye study was attempted on (b)(6) 2019, but the hcp couldn't "evacuate the medication from the catheter line" so the dye study was aborted.The patient's ptm and pump were "turned off" as the hcp said he didn't know where the medication is going and the patient was going to be scheduled for surgery.The patient noted that once the surgery was scheduled he may just ask the hcp to remove the pump entirely instead of repairing the issue.He visited his primary care provider and was told he couldn't take any medication right now, not even aspirin, as his body had "to absorb the morphine that had been released in his body" and that was why his pump was stopped.Additional information received on 2019-mar-18 indicated that the patient decided to have the pump removed entirely.The surgery to remove the pump was scheduled for (b)(6) 2019.He wanted to know why the pump was "messed up." he was redirected to discuss the issues with the surgeon after the surgery.Additional in formation from the patient indicated that when the doctor removed more medication than expected on (b)(6) 2018, it was only "a couple more ml more than it should have been." 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: 8206795
• MDR Text Key: 131733599
• Report Number: 3004209178-2018-28518
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2019
• Date Device Manufactured: 06/12/2015
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 55 YR