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

Model Number 8637-20

Device Problems Migration or Expulsion of Device (1395); Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Pain (1994); Complaint, Ill-Defined (2331); Malaise (2359)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8784, serial#: (b)(4), implanted: (b)(6) 2019, product type: catheter; product id: 8780, serial#: (b)(4), implanted: (b)(6) 2019, product type: catheter.Other relevant device(s) are: product id: 8784, serial/lot#: (b)(4), ubd: 20-jun-2021, udi#: (b)(4); product id: 8780, serial/lot#: (b)(4), ubd: 11-mar-2021, udi#: (b)(4).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 intrathecal unknown morphine (concentration and dose unknown) via an implanted pump.It was reported the patient had been having an issue with her pump and so, she has had saline in it for almost three months.It was noted she was scheduled for surgery to remove it on (b)(6) 2020 but because of the covid virus the surgery in (b)(6) was cancelled six hours before ¿because (b)(6), was where they were sending all the covid cases.¿ it was also reported the patient¿s healthcare provider (hcp) now wanted her to find an hcp to remove it immediately who was closer to where she lived in (b)(6), but she was having trouble finding someone.It was clarified she needed her pump removed immediately because it was protruding, dislodged, she could not sit up.It was noted she had to wear a band to keep it from moving.It was reported the patient had to get this out as she was in a lot of pain, her blood pressure was so high, the pump moved into her ribs mid-week last week and it was actually moving, so now she was trying to wear a waist band, trying to keep it tight and it hurt to breath.Regarding the event date, the patient reported her hcp had moved her pump twice, the first time it looked like she ¿had a butt implant,¿ he had a bad placement and did not hook up the catheter.It was reported the patient was so sick because the medicine was going into her system.It was also reported the latest part dislodged probably about mid (b)(6) (2020) so the hcp put her on surgery schedule; however, the hcp had to lower her off the morphine and when she still had three weeks to go, they turned pump off completely which sent her into withdrawals and she ended up in the hospital.The event date was asked and unknown.The patient was redirected to the hcp to discuss next steps and an email was also sent to the company representative¿s in the area.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: 9922827
• MDR Text Key: 196577047
• Report Number: 3004209178-2020-06682
• 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: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2020
• Date Device Manufactured: 02/27/2019
• 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 Outcome(s): Required Intervention