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

Model Number 8637-20

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Fatigue (1849); Hypoxia (1918); Decreased Respiratory Rate (2485); Insufficient Information (4580)

Event Date 04/16/2022

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 regarding a patient receiving dilaudid 15mg/ml at 5mg/day via an implantable pump.The indication for use was spinal pain.The healthcare provider reported that on tuesday the patient¿s drug was ¿upped" on tuesday and caused the patient to have overdose like symptoms.The reporter stated the patient came into the er (emergency room) with overdose symptoms and they are concerned that there is an issue with the pump or within the drug in the pump.The reporter did not have a clinician tablet so they were not able verify any of that information yet.The reporter was redirected to the nas (national answering service) to page a local representative.Additional information was received on 18-apr-2022 from the company representative who reported that they had received a call from the clinician who stated the patient presented into the clinic again today with signs and symptoms of overdose that mimicked exact presentation of the previous report (see manufacturers report number 3004209178-2022-00836).The patient had their pump refilled on (b)(6) 2022 at the pain clinic and followed a similar course.Within an hour she started exhibiting somnolence and slow, shallow respirations.The patient was admitted into an emergency room in (b)(6) last weekend, oxygen saturation was 60% and was given narcan then transferred down to (b)(6).Per the managing clinician the patient¿s current concentration is dilaudid 15 mg per ml infusing at 5 mg every day.Residual volume of medication from the reservoir was an actual 17.0 ml's versus an expected 18.5 ml's.The patient had experienced a fall shortly after her pump was replaced on (b)(6) 2022.The physician stated the patient has so much hardware that a dye study may not be feasible for troubleshooting.A rotor study has not been done.A sample of the medication from her pump reservoir was sent out to be analyzed but results won't be back for two weeks.The physician also stated the patient has had extensive spine surgery since her most recent catheter was implanted on (b)(6) 2015.The physician is going to consult with the neurosurgeon about the possibility of replacing the existing catheter and the existing pump.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14165540
• MDR Text Key: 289732443
• Report Number: 3004209178-2022-05032
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000422608
• UDI-Public: 00763000422608
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2023
• 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: 04/16/2022
• Date Device Manufactured: 08/16/2021
• 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
• Patient Age: 66 YR
• Patient Sex: Female