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 Seizures (2063); Therapeutic Response, Decreased (2271); Shaking/Tremors (2515)

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 regarding a patient receiving morphine via an implanted infusion pump.It was reported that about a year ago the patient had withdrawal.It was noted the hcp was in training and got fired.The hcp turned the pump off and about a day later the patient started convulsing and their legs/arms were flailing.The patient ended up in the hospital and thought they were going to die.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10831373
• MDR Text Key: 215976471
• Report Number: 3004209178-2020-19894
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2020
• Date Device Manufactured: 10/07/2015
• 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