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

Model Number 8637-20

Device Problems Electromagnetic Interference (1194); Insufficient Flow or Under Infusion (2182); Environmental Compatibility Problem (2929)

Patient Problems Therapeutic Response, Decreased (2271); Malaise (2359)

Event Date 07/27/2019

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 consumer regarding a patient receiving morphine and another unknown drug at unknown concentrations and doses via an implantable infusion pump.The indication for use was noted to be spinal pain.It was reported that the patient had a refill prior to leaving for vacation.While on the flight he didn't "feel very great" and just thought it was due to sitting too long, but then they started getting sick and had symptoms of withdrawal.They called the patient's managing health care professional (hcp) in his home state and he told them that the "airport security affected the pump resulting in the medication to be dispensed incorrectly." the caller was encouraged to follow up with a local hcp to check the pump and potentially seek medical attention for the symptoms.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a health care professional on 2019-aug-07.It was reported that the airport scanner may have caused a pump stall as the patient reported symptoms of withdrawal on the day of travel.The pump had not been interrogated and the cause of the withdrawal had not been determined.The patient was given oral ativan for withdrawal.The patient would be assessed when he returned from his vacation.The patient's weight was unknown.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: 8852414
• MDR Text Key: 162050931
• Report Number: 3004209178-2019-14822
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2019

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: 05/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 08/01/2019
• Supplement Dates Manufacturer Received: 08/07/2019
• Supplement Dates FDA Received: 08/09/2019
• Date Device Manufactured: 12/07/2017
• 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
• Patient Outcome(s): Other
• Patient Age: 58 YR