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

Model Number 8637-40

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Vomiting (2144); Malaise (2359); Sleep Dysfunction (2517); No Known Impact Or Consequence To Patient (2692)

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 friend/family member regarding a patient who was receiving 2000 mcg/ml of baclofen at 599. 6 mcg/day via an implantable pump for intractable spasticity. It was reported that the patient's pump was "not functioning well". The consumer reported that the patient would go into a "sleep coma". Sometimes the patient would sleep for a whole 24 hours if allowed, noting that the patient would go to bed at 8pm, sleep through the night, and at 10 am still be sleeping. The patient would sometimes need to be physically woken, though the consumer noted that the patient would "look at you for a few seconds and then go back to sleep". After waking the patient, the consumer would give the patient something to eat and the patient will then go back to sleep. The consumer also noted that the patient would "projective vomit all over", stating that the patient will be really sick in the morning and cannot get up from bed. This sickness would go on for the entire day for 2 days. According to the consumer, the patient was sick in bed throwing up. These issues had been going on for about a year, but the year was not confirmed. The consumer had read online that if the patient is getting too much baclofen at one time, "it could set into a slip coma". The consumer had also read that if the patient does not get enough baclofen, there could be vomiting episodes with sickness. The consumer had voiced their concerns with the patient's healthcare provider (hcp) but the hcp did not seem to suggest anything. The hcp did a dye test and there was nothing wrong with the catheter that the hcp could find. No out of box failures or medical/therapy problems associated with a small components product were reported.  and no further patient complications are anticipated or expected as a result of this event.

• 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: 9505030
• MDR Text Key: 183568300
• Report Number: 3004209178-2019-24261
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/28/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/30/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial