MAUDE Adverse Event Report: MDT 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 Fall (1848); Overdose (1988); Pain (1994); Dysphasia (2195); Complaint, Ill-Defined (2331)

Event Date 05/09/2018

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 drug infusion device.The drug being delivered was morphine (unknown) with an unknown dose and concentration.The reason for use was non-malignant pain.It was reported that the patient "has spent the last couple days in the hospital¿ because they fell last thursday "and busted up her lip".The patient didn't receive help at the hospital "because of course they think she is a drug addict".The caller says that "it seems like she is taking too much medication even though she isn't, but she isn't even taking all of her pills, and she will be fine one minute and the next she will be slurring her words and all happy and then she will be ok again".This started "a couple months ago (prior to the call date of (b)(6) 2018) and its slowly progressed and then a few weeks ago it¿s gotten worse".The patient had a fall last thursday ((b)(6) 2018 ) "and she had a fall a month or 2 before that as well" (2018).No interventions were mentioned.The patient has a pump refill this thursday ((b)(6) 2018), and so it was reviewed that the healthcare professional (hcp) can call to page a manufacturer¿s representative (rep) to be at the appointment.The situation is being addressed by the hcp.There were no further complications reported/anticipated.

Manufacturer Narrative

Correction- hospitalization also applies.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7736408
• MDR Text Key: 115646962
• Report Number: 3004209178-2018-17078
• Device Sequence Number: 0
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2013
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 05/17/2012
• 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; Other
• Patient Age: 61 YR