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

Model Number 8637-20

Device Problems Difficult to Interrogate (1331); Unstable (1667)

Patient Problems Headache (1880); Pain (1994); Swelling (2091); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was provided by a consumer regarding an implantable intrathecal pump intended to deliver fentanyl [500.0 mcg/ml] at 181.33 mcg/day and bupivacaine [25.0 mg/ml] at 9.066 mg/day, indicated for non-malignant pain.It was reported that the patient felt the pump has moved or has tilted.The event date was unknown, per the patient ¿about a week ago¿ from the report date ((b)(6) 2018).It was stated that she could always feel the notches at the top of the pump, which is always at a tilt, but has never been able to feel the whole pump.It was stated that it feels like the bottom has settled and is more in the stomach, and the top is sticking out.The patient reported that on (b)(6) 2018, she experienced migraines that go across the cheeks and eyes and her eyes are swollen and ¿vluty,¿ and the pain is going up into her head, and coming down into the back of the neck and top of the shoulders.It was also reported that the patient feels she is not getting her personal therapy manager (ptm) over the pump in the right area.The patient reported that on (b)(6) 2018, she was not feeling the bolus.It was stated that she normally feels a warmth as the bolus delivers, and she had not felt the warmth from the last two boluses.It was noted that the patient considered the change in therapy/symptoms gradual.It was stated that the patient had not had any falls or traumas.The patient was redirected to follow-up with her managing physician.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: 7407140
• MDR Text Key: 104811625
• Report Number: 3004209178-2018-06746
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2018
• Date Device Manufactured: 04/06/2017
• 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