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

Model Number 8637-40

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Seizures (2063); Vomiting (2144); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Injury (2348); Weight Changes (2607)

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 consumer (patient¿s wife and patient) regarding a patient who was receiving morphine with a concentration believed to be 20 mg/ml at a dose rate of 2.5 mg/day via an implantable pump for spinal pain.It was reported that the patient¿s pump had ¿malfunctioned or went out" approximately 4 months ago (day, month and year unknown).It was further reported that the patient was unable to keep depakote (anti-seizure medicine) down.The patient kept throwing it up and last time in 10 days they had lost 22 pounds and had a massive seizure.The patient was described as having woke up in the bathroom all tore up and bleeding.The date of the pump having malfunctioned / went out resulting in a massive seizure, patient having been tore up and was bleeding, and weight loss was unknown (day, month, and year unknown).It was noted that the patient¿s biggest problem was that they have a terminal illness (onset date unknown).The patient has had ¿40-some surgeries¿ and the anesthesia and they had to keep increasing it; the patient had a ¿toxicity thing¿ that causes seizure disorder; date of events was unknown.No further patient complications have been reported as a result of this event.

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: 8503927
• MDR Text Key: 141598858
• Report Number: 3004209178-2019-07169
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2019
• Date Device Manufactured: 04/08/2014
• 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): Other
• Patient Age: 47 YR