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

Model Number 8637-40

Device Problems Insufficient Flow or Under Infusion (2182); Unintended Electrical Shock (4018)

Patient Problems Dyspnea (1816); Overdose (1988); Pain (1994); Complaint, Ill-Defined (2331); Loss of consciousness (2418)

Event Date 07/11/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from the healthcare provider (hcp) via a device manufacturer representative regarding a patient receiving an unknown drug via an implantable infusion pump.The indication for use was non-malignant pain.It was reported that about a week and a half ago a volume discrepancy was noted (expected reservoir volume 5 and the actual reservoir volume was 36).On (b)(6) 2019 the patient was experiencing pain he took additional oral medication as well as several sleeping pills and presented at the emergency room unresponsive.It was noted that the patient's family thought he was getting too much medication.The pump was turned down to minimum rate and the patient was reported as "fine".The caller was redirected to follow up with the healthcare provider (hcp).No further complications have been reported as a result of this event.Additional information received from a manufacture representative reported that on 2019-jul-21, the hcp refilled the pump and got 34ml when they expected 5 ml.A roller study was performed and the rollers moved.The hcp did not want to do a cap aspiration or dye study because they did not believe a catheter issue could cause this large of a volume discrepancy.The patient wanted the pump explanted and they plan to replace the pump in the future but cannot now due to the workers comp.The date of replacement was not known at this time.No symptoms 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 consumer indicated that the amount of drug found to still be in the pump during the refill meant the pump was not working.It was reported that the patient felt a "zap" at the pump area; the pump began working and the patient felt "higher than a kite".The patient was later unable to woken up, hardly breathing and was delivered narcan.The patient spend several days in the hospital, was on a respirator and have to their kidneys flushed.The pump was checked and noted to be working fine and was turned back on.No further complications have been 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: 8869138
• MDR Text Key: 153523129
• Report Number: 3004209178-2019-15116
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2019
• Date Device Manufactured: 08/18/2015
• 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 Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 62 YR