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

Model Number 8637-40

Device Problems Filling Problem (1233); Fluid/Blood Leak (1250); Excess Flow or Over-Infusion (1311); Overfill (2404); Device Ingredient or Reagent Problem (2910); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Overdose (1988); Pain (1994); Vomiting (2144); Dizziness (2194); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Toxicity (2333); Malaise (2359); Cognitive Changes (2551)

Event Date 09/01/2016

Event Type  Injury  

Event Description

Information was received from a healthcare professional (hcp) via company representative regarding a patient receiving dilaudid (20mg/ml at 3mg/day) via an implanted pump.The indication for pump use was non-malignant pain.On (b)(6) 2017 the patient reported grogginess, nausea, and difficulty concentrating following the refill and went to the er (emergency room).The patient was given narcan in the ambulance and at the er.The actions/interventions taken were that the patient received medicine and was monitored.The pump was interrogated and telemetry was run.No alarms showed and everything was normal on telemetry.The issue was resolved.The patient status was reported as ¿alive ¿ no injury¿.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Device code (b)(4) no longer applies to the pump.Instead device codes (b)(4) apply to the pump.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from consumer on 2017-jul-12 reported the healthcare professional (hcp) "almost killed" on (b)(6) 2017.It was stated the hcp did not remove the left over drug from the pump and they tried to force 40 ml in at the patient's refill.The patient stated 7ml was left in the pump.The patient was overdosed and had to go to the hospital.The patient was given three shots of narcan in the hospital.It was noted that the patient was gone and out of it.It was stated that at the refill the hcp kept probing and there was blood in the vial.The manufacturer representative came to the hospital the same day with the programmer.The patient requested hcp listings.Hcp listings were provided/sent.The patient was redirected to their hcp.No further complications were reported/anticipated.

Manufacturer Narrative

Corrected information: device code (b)(4) no longer applicable.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the healthcare provider indicated that there was no difficulty injecting or locating the refill septum in clarification regarding the probing.The healthcare provider had called in as this problem happened twice.The patient was injected with full 40cc in their pump and the healthcare provide believed there was leakage from the pumps insertion site and caused extravasation of medicine causing acute toxicity.On the recheck after the filling the patient had expected amount of medicine but the was visual leak at needle insertion site.Per the healthcare provider in the future, either the injection amount be reviewed or injection site reviewed to make sure there is no leak.Additional information received from the patient reported that the patient wanted to know how to get the pump removed.No further patient complications were reported.

Manufacturer Narrative

Should be adverse event and product problem.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received on 2017-aug-15 from a consumer.It was reported that during a refill, the nurse "bursted it up," and the patient vomited for 7 days and wound up in 2 different hospitals.When the patient was driving home, he reportedly got "real sick and dizzy" and he thought he had the flu.The patient reportedly started vomiting and tried to reach the hcp (on a saturday), but couldn't reach anybody.The patient ended up at a hospital where they did blood work, but because they were unfamiliar with the pump, they sent the patient home.The following sunday, the patient drove to another hospital but "they couldn't do nothing" or "reach his doctor." it was additionally reported that "something was not right" with the patient's pump because of severe back pain, and the patient felt like he was going through severe withdrawal.It was noted that it was hard to explain what the patient was going through, but it was confirmed that the reported information was related to the previously reported od following refill.It was furt her noted that the event occurred in (b)(6) 2016 (note: this conflicts with the previously reported information stating that the event occurred in (b)(6) 2017).Regarding the drug dose and concentration, the patient noted "3 milliliters" but she "pushed it up to 3.5," but it was unclear whether this was in reference to the dose or concentration.At the time of this report, it was noted that the patient was in between doctors and had an appointment in (b)(6) 2017 for the pump.The patient wanted to find another hcp because it was noted that "somethings wrong with the pump." the patient was to try to reach out to his hcp to see if he could get the pump checked earlier.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer (con).It was reported that when the patient's healthcare professional (hcp) filled his pump, "there was 7 ml in my pump, and he tried to push 40 ml in and pushed the 7 ml in my system".When the 7 ml was pushed into his system it had dilaudid instead of morphine.Because of this, the patient was taken to the hospital by ambulance and spent 24 hours in the hospital.The patient knew something was not right after that refill and he soon "started to lose it".The patient said "i guess i passed away because i was experiencing different things" during the hospital stay.The patient reported the hcps at the hospital had to shoot narcan in the patient.The patient reported that a manufacturer's representative (rep) was there and told him everything that happened.The patient did not currently have a physician that was trained with the pump that he can go to.The patient's pump was "not putting working" because he was not putting out like it should.The patient needed to get his pump checked and turned up because they turned it down and "it's not putting out like it should".The patient saw blood in the syringe that the hcp used to refill the pump.The patient had never seen blood in a syringe used for a refill before.Additional information was received from a consumer (con).It was reported thatwhen the patient's pump was over filled the patient saw blood in the tube.

• 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: 6613860
• MDR Text Key: 76731436
• Report Number: 3004209178-2017-11676
• 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,Followup,Followup,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2016
• 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: 11/08/2017
• Date Device Manufactured: 10/28/2014
• 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; Required Intervention
• Patient Age: 68 YR