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

Model Number 8637-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Overdose (1988); Sedation (2368); Decreased Respiratory Rate (2485)

Event Date 08/28/2018

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 an unknown intrathecal medication via an implanted pump for non-malignant pain and lumbar radiculopathy.The reporter requested to contact a local company representative (rep) and required troubleshooting assistance.The hcp needed possible assistance with the programmer for the patient.The patient was in the emergency room (er) with overdose symptoms.The event date was (b)(6) 2018.No further complications were reported/anticipated or expected.

Manufacturer Narrative

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

Event Description

Additional information was received via company representative.The cause of the overdose symptoms was unknown.The patient was being transferred to another hospital where a physician had privileges and could see the patient.The physician¿s name and phone number were provided.

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) indicated in regards to the overdose symptoms there was a ¿device issue¿ further clarified as trying to go from minimum rate back to continuous was too large of a jump.The patient experienced respiratory depression/sedation.The pump rate was decreased, and the patient was treated with a narcan drip until symptoms resolved.It was noted the new clinician software was used with this event.The patient was fine and no long-term sequela.The patient¿s weight at the time of the event was ¿(b)(6)¿ pounds.It was further reported the device was working fine.No further complications were reported/anticipated or expected.

• 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: 7833730
• MDR Text Key: 118789058
• Report Number: 3004209178-2018-19574
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 08/30/2018
• Supplement Dates Manufacturer Received: 08/30/2018; 09/04/2018
• Supplement Dates FDA Received: 08/31/2018; 09/06/2018
• Date Device Manufactured: 05/16/2014
• 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; Required Intervention
• Patient Age: 90 YR
• Patient Weight: 109