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

Model Number 8637-20

Device Problem Data Problem (3196)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2018

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 healthcare professional regarding a patient who was receiving morphine (5.0 mg/ml, 0.4179 mg/day) via intrathecal drug delivery pump for spinal pain.It was reported that the doctor interrogated the pump just to get the refill date and updated the pump with no changes.The pump logs showed the flow rate of the pump was about 0.08 ml/day (0.08358 ml/day).On (b)(6) 2018 at 12:26, the reservoir volume was 10.1 ml, the refill interval was 96 days, and the low reservoir alarm date was (b)(6) 2018.After the update on (b)(6) 2018 at 12:27, the reservoir volume was 10.0 ml, the refill interval was 95 days, and the low reservoir alarm date was (b)(6) 2018.The reservoir volume had decremented down 0.1 ml.The doctor wanted to know why this happened and was concerned for the patient.The patient was still there and had no symptoms when asked.The doctor reviewed the pump again, and the reservoir volume went back to 10.1 ml, and the low reservoir alarm date to (b)(6) 2018.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: 7944511
• MDR Text Key: 124512244
• Report Number: 3004209178-2018-22533
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2018
• Initial Date FDA Received: 10/08/2018
• Date Device Manufactured: 01/21/2015
• 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 Age: 70 YR