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

Model Number 8637-40

Device Problems Volume Accuracy Problem (1675); Improper or Incorrect Procedure or Method (2017)

Patient Problems Bradycardia (1751); Fatigue (1849); Nausea (1970); Vertigo (2134); Vomiting (2144); Malaise (2359)

Event Date 04/25/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a foreign health care provider (hcp) via a manufacturer representative regarding a patient who received clonidine (600.0mcg/ml, 149.96mcg/day) in an implantable pump for an unknown indication for use.The patient medical history and concomitant medications were unable to be obtained.Two hours following a refill on (b)(6) 2018 (approximately 16:30), the patient experienced vomiting, nausea, sleepiness (also reported as tired), vertigo, bradycardia, dry mouth, and did not feel well.The pump was emptied and 3.4ml of drug was missing.The expected reservoir volume (erv) was 39.9ml and the actual reservoir volume (arv) was 36.5ml(confirmed via provided session report).The issue was considered to be due to a pocket fill.There were no known environmental/external/patient factors that may have led or contributed to the issue.The refill was considered normal and nothing was noticed (in agreement with telemetry).The provide telemetry report from the refill indicated the erv was 17.3ml and the arv was 17.5ml.The pump was programmed to minimum rate.The patient was kept for monitoring.On (b)(6) 2018, the patient had no issue through the night.The patient was discharged and programming was resumed to clonidine 150mcg/day (plus 3 x 19.99mcg bolus).The issue was considered resolved.The status of the patient was stated to be alive and with no injury.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received.It was reported that the pump was refilled on (b)(6) 2018 at 13h30m with 40 ml clonidine with patient activations of 20 mcg 3x/day.It was reported that 4 hours after leaving a hospital, the patient arrived at the emergency.It was reported that the patient experienced no hypertension.It was reported that the event resulted in in-patient or prolonged hospitalization and the intervention was reprogramming that occurred on (b)(6) 2018.The pump was reprogrammed to 3.65 mcg/day.It was reported that the event was related to the device or therapy.The event was reported as resolved without sequelae (b)(6)2018.No further complications were reported and/or anticipated.

• 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: 7496922
• MDR Text Key: 107689672
• Report Number: 3004209178-2018-10418
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2016
• 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: 11/14/2018
• Date Device Manufactured: 03/31/2015
• 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