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

Model Number 8637-20

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Overdose (1988); Complaint, Ill-Defined (2331); Sedation (2368)

Event Date 05/11/2018

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 healthcare provider (hcp) regarding a patient receiving morphine(25 mg/ml, 2.5 mg/day) via an implantable infusion pump for the treatment of non-malignant pain.It was reported that 20 minutes prior to the call, a pocket fill occurred during pump refill.The amount of drug that went sub-q (subcutaneous) was unknown.The patient seemed more sedated so they started an iv(intravenous) and administered narcan.The patient "perked up" when the narcan was given.The patient is currently at the out-patient clinic and would be transferred to the hospital and monitor in-patient.The healthcare provider (hcp) would access the pump to see how much drug was in the reservoir.Refill kit is always utilized and it was unknown why the pocket fill occurred.This was considered a sudden change in therapy/symptoms.No further complication was reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider (hcp).It was reported that the patient was in the intensive care unit (icu) and was intubated.The patient weight was unknown, but the patient was noted to be "heavy." no further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the food and drug administration (fda) and a healthcare provider.It was reported that the patient received an overdose of medication during a standard pump refill.It was determined that there may have been a malfunction of the device or there was a rare complication that occurred of pocket filling.The patient refused explant of the device to assist with further investigation of the pump.

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: 7510750
• MDR Text Key: 108144816
• Report Number: 3004209178-2018-10794
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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: health professional,other
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 08/12/2017
• 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; Life Threatening; Required Intervention
• Patient Age: 65 YR