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

Model Number 8637-20

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Overdose (1988); Respiratory Distress (2045)

Event Date 05/13/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received via a manufacturer representative (rep) from a patient who was receiving dilaudid, 25 mg/ml concentration at 0.160 mg/day dose and fentanyl, 25 mg/ml concentration at unknown dose via intrathecal drug delivery pump for unknown indication for use.It was reported that after a refill the patient started to exhibit symptoms of overdose.Patient was seen in hospital.Patient reported pocket fill during refill at hcp's office.Patient was refilled in to the pocket rather than in to pump.Patient began having respiratory distress.Patient was taken to hospital and given narcan.Pump was stopped by another rep on monday.Pump was interrogated to confirm stopped status.Any environmental/external/patient factors that may have led or contributed to the issue were pump refill.The pump was initially placed on minimum rate and subsequently turned off in ed per emergency room healthcare professional (hcp).At the time of this report, the issue had not resolved and patient status was alive- injury.Patient was admitted to hospital per er.The patient¿s medical history included chronic pain.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: 8621271
• MDR Text Key: 145418887
• Report Number: 3004209178-2019-09842
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2019
• Date Device Manufactured: 02/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1060-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 36 YR