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

Model Number 8637-40

Device Problems Unstable (1667); Volume Accuracy Problem (1675); Torn Material (3024)

Patient Problems Pain (1994); Underdose (2542)

Event Date 04/05/2017

Event Type  Injury  

Event Description

Information was received from a health care professional via a company representative regarding a patient who was receiving morphine (concentration 5000 mcg/ml, dose 339.5 mcg/day) via an implantable pump for non-malignant pain and failed back surgery syndrome.On this report date during servicing (refill) the doctor aspirated 9ml of drug from the pump reservoir when the pump interrogation was showing that the pump should only have had 1ml of drug in the reservoir.It was unknown as to what factors may have led or contributed to the issue.There were no diagnostics/troubleshooting/actions/interventions taken.Surgical intervention did not occur and it was unknown as to whether it was planned.At the time of this report, the issue was not resolved and patient status was ¿alive ¿ no injury¿.The company representative had called the patient and left a voice mail and had not been able to speak to the patient yet, there was a lot unknown at the time of this report.There were no symptoms mentioned.No further complications were reported.2017-05-17 fu1-96590-d.Hickmanpumptelemetry.Pdf, fu1-mpxr-36481-2017-05-17.Pdf, crts3557114 (hcp, rep): the company representative spoke with medical assistant at the doctor¿s office on this report date.A refill was performed on this report date.The medical assistant stated that the pump was filled on (b)(6) 2017 with 20cc of morphine 5mg/ml, 449.3 mcg/day.At today's refill, the ma stated that t he reservoir volume read 16.2 in the reservoir.However, 20cc of drug was aspirated from the reservoir indicating that none of the drug was delivered to the patient.They had not read the logs for this patient.They discussed reading the logs next time the patient is seen.The doctor had requested that the patient get an x-ray to look at the catheter position.A catheter access port aspiration and dye study was also suggested they were also planning for a replacement for the pump and were wondering about pump warranty.The company representative submitted all telemetry reports for this patient except the telemetry from today's refill and was to send it once he got it.Also, at last pump refill on (b)(6) 2017, the patient was not stating any issues with pump.At today's pump refill the patient reported a pain level of 1.It seemed the patient¿s pain level was at a very low level.It was noted that the issue was first noted after the first refill after implant.A session data report was provided.As examined on (b)(6) 2017, the drug in pump was morphine (concentration 5000 mcg/ml, dose 449.3 mcg/day) the estimated elective replacement indicator was 73m.No further complications were anticipated/reported.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The health care professional planned to replace the pump and utilize the existing medication in the old pump to the new pump.The logs had not been checked yet but the company representative planned to do that.They were doing microdosing with compounded drug typically.Reportedly it was astonishing with the varying concentrations from compounded pharmacies when drug gets tested so the company representative was going to see about testing the drug.The company representative planned to return all explanted products to the manufacturer for analysis.

Manufacturer Narrative

Other applicable components are: product id (b)(4) lot# serial# (b)(4) implanted:(b)(6) 2016 explanted: (b)(6) 2017 product type catheter.Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer's representative(rep) on 2017-jun-28.The patient's pump and catheter were replaced on (b)(6) 2017.It was reported that during the explant procedure, it was noted that the sutures were not intact, and the pump was not secured in the pump pocket.It was stated that this was the only information the rep had to add to the previously reported information.Print-outs of the pump settings and event logs at the time of explant were provided.No anomalies were noted.The estimated eri (elective replacement indicator) was at 71 months.No further complications were anticipated/reported.

Manufacturer Narrative

Information referenced the main component of the system and other applicable components are: product id 8780 serial(b)(4)) implanted:(b)(6) 2016 explanted: (b)(6)2017 product type catheter the pump was returned for analysis.Pump analysis found no anomaly with the device.The catheter was returned for analysis.Catheter analysis found significant twisting that may have affected infusion.The device code (b)(4) no longer applies and (b)(4) was added.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.

• 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: 6636087
• MDR Text Key: 77394120
• Report Number: 3004209178-2017-12689
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2016
• 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): Required Intervention
• Patient Age: 70 YR