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

Model Number 8637-40

Device Problems Excess Flow or Over-Infusion (1311); Pumping Stopped (1503); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Application Program Problem (2880); Infusion or Flow Problem (2964)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 03/11/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_cath, lot# unknown, serial# unknown, implanted: unknown, explanted: n/a, product type catheter.Other relevant device(s) are: product id: neu_unknown_cath, serial/lot #: unknown, ubd: unknown , udi#: asku.(b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving morphine 10 mg/ml at 7.495 mcg/day via an implantable pump for an unknown indication for use.It was reported that the patient experienced withdrawal symptoms and went to the hospital.It was reported that there were no environmental/external/patient factors that may have led or contributed to the issue that they were aware of.It was reported that a refill procedure was performed and the expected drug volume was 9.4ml and the aspirated drug volume was 0.0ml.It was reported that a sideport control was performed and approximately 1ml was aspirated from the sideport.A rotor control with x-ray control was programmed via the tablet (fill bolus of 0.010ml in 1min) did not show any movement with x-ray picturing.A catheter visibility control was done via sideport with contrast agents was not successful, it was not possible insert fluid (contrast agents) via sideport.It was reported that the pump is now programmed on minimal flow.The issue was not resolved at the time of this report.It was reported that no surgical intervention was performed and it was unknown if any surgical intervention was planned.The patient status at the time of the report was alive-no injury.No further complications were reported and/or anticipated.

Manufacturer Narrative

Product id: neu_unknown_cath, lot# unknown, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported that the patient's age and weight would not be provided by the physician due to data security.It was reported that no empty pump alarm was mentioned by the patient.It was reported that pump logs were not available.It was reported that an explant of the entire system was performed on (b)(6) 2019.The explanted synchromed ii pump is still at the hospital's place, but will be returned for analysis.No further complications were reported and/or anticipated.

Manufacturer Narrative

Product id: 8780, lot# 0208920725, serial# n/a, implanted: (b)(6) 2015, explanted: (b)(6) 2019, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported that the catheter model was confirmed to be 8780 with a lot number of 0208920725.It was reported that the implant date of the catheter was (b)(6) 2015.It was reported that the patient's symptoms have been resolved.It was inquired if any messages indicated a motor stall were present when the pump was interrogation and it was reported that there were no messages.It was inquired if the correct date of the event was (b)(6) 2019, and it was reported that the date of being notified by the physician of this event was (b)(6) 2019.No further complications were reported and/or anticipated.

Manufacturer Narrative

Product id: 8780, lot# unknown, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received via a foreign user report.It was indicated that there was a suspected catheter obstruction and "dysfunction" of the implanted drug pump.It was noted that the patient also experienced pain exacerbations.

Manufacturer Narrative

Analysis of the pump identified damage to the septum, however, it did not result in a leak during bench testing in the laboratory.Analysis of the catheter identified an occlusion in the pin connector which is consistent with dried drug, blood or other foreign material.(b)(4).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: 8425638
• MDR Text Key: 139073338
• Report Number: 3004209178-2019-05380
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2014
• 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): Required Intervention