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

Model Number 8637-20

Device Problems Failure To Service (1563); Insufficient Flow or Under Infusion (2182)

Patient Problems Nausea (1970); Pain (1994); Therapeutic Response, Decreased (2271); No Code Available (3191)

Event Date 06/27/2018

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 consumer regarding a patient receiving intrathecal fentanyl (concentration and dose unknown) via an implanted pump for spinal pain and degenerative disc disease.It was reported the patient was currently admitted for possible withdrawal symptoms and no troubleshooting was done prior to the call.The caller did not have access to a programmer for further troubleshooting.The patient was currently in the hospital and possibly having withdrawal symptoms.It was reported the alarm never went off and the patient was told she was not due for ¿shot until the 3rd.¿ it was also reported the patient did not know she had withdrawal symptoms, but something occurred later that she must be out of mediation.The reporter stated never got an alarm.The patient was admitted to the hospital on (b)(6) 2018 after she took herself there.She had symptoms such as terrible back pain like withdrawal symptoms such as yawning and feeling nauseated.The healthcare provider (hcp) gave her pain medications to take.It was noted the patient was given the wrong date and the alarm never went off.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: 7654944
• MDR Text Key: 112879684
• Report Number: 3004209178-2018-14756
• 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: consumer
• Type of Report: Initial
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2018
• Date Device Manufactured: 12/02/2014
• 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): Hospitalization
• Patient Age: 75 YR