MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED EL; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8627L18

Device Problem Use of Device Problem (1670)

Patient Problems Dyspnea (1816); Emotional Changes (1831); Nausea (1970); Pain (1994); Vomiting (2144); Therapeutic Response, Decreased (2271)

Event Date 04/17/2004

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer and a health care professional (hcp) regarding a patient receiving an unknown drug at an unknown concentration and dose via an implantable infusion pump.It was reported that the patient called the hcp on (b)(6) 2004 stating she was having extreme pain in her lower extremity from the waist downward.She was "essentially crying" on the phone.She was told to go to the emergency room (er).The er called the managing hcp later that day to ask what the hcp wanted done with the patient.It was noted the patient needed to come in for a pump refill and the hcp asked that the patient's pain be managed by the er until she was able to come in for a fill.The patient's son called the hcp on (b)(6) 2004 to report that the patient was still having nausea, vomiting and pain in her back and legs.She had been treated in the er with morphine tablets and sent home.She was still crying.She also was having trouble breathing due to the morphine tablets and morphine injection given in the er.The son was told that there was little the hcp could do for her until she could get in to the office for a pump refill.The patient called the hcp the same day.It was noted the patient's pump was supposed to be filled the previous week, relative to (b)(6) 2019.Upon further discussion with the patient on (b)(6) 2019 when she presented for a refill, the patient's sister had not relayed the message that the hcp's office had left for her regarding the pump refill, which is why the refill was missed.The patient still had some withdrawal symptoms with nausea, vomiting and pain.The patient was noted to be stable with the previous infusion of morphine through her pump.The refill was performed without incident and the patient was given a 2mg bolus to help with the withdrawal symptoms.The importance of prompt pump refills was stressed to the patient.No further complications were reported.

• Brand Name: SYNCHROMED EL
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8332338
• MDR Text Key: 136267501
• Report Number: 3007566237-2019-00345
• Device Sequence Number: 1
• Product Code: LKK
• 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,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2003
• Device Model Number: 8627L18
• Device Catalogue Number: 8627L18
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2019
• 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: 38 YR