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

Model Number 8637-40

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Overdose (1988); Decreased Respiratory Rate (2485); Lethargy (2560)

Event Date 04/30/2018

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 health care provider (hcp) regarding a patient receiving morphine at an unknown concentration and dose via an implantable infusion pump.The indications for use were noted to be non-malignant pain and other chronic/intractable pain (trunk/limbs).It was reported that the patient was having symptoms following a dose increase.The doctor gave the patient narcan which helped the symptoms.The reported symptoms were lethargy, slow breathing and lowered blood pressure.The patient was admitted to the hospital on (b)(6) 2018.No further complications were reported.

• 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: 7479648
• MDR Text Key: 107107736
• Report Number: 3004209178-2018-09847
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2018
• Date Device Manufactured: 06/08/2016
• 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; Required Intervention
• Patient Age: 64 YR