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

Model Number 8637-20

Device Problems Difficult to Interrogate (1331); Device Displays Incorrect Message (2591)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 05/09/2015

Event Type  Injury  

Event Description

It was reported the patient experienced withdrawal.It was noted an alarm was heard and telemetry confirmed an empty reservoir had occurred.The patient first heard the alarm on (b)(6) 2015.The medication was ordered for the pump but the healthcare provider (hcp) would not be getting it for a couple of days at least.The pump was filled with preservative free normal saline.The patient presented to the emergency room on (b)(6) 2015 with sudden onset of vomiting, nausea, and increased pain.The patient was still in the hospital.Intravenous pain and other medications were administered for symptom relief.The follow up doctor was contacted about the issue.The hcp was experiencing issues with performing telemetry on the pump on the date of this report but did not have issues the day prior.The drugs being delivered via the device system were bupivacaine, baclofen, and morphine.No outcome information was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant products: product id 8709sc, serial # (b)(4), implanted: (b)(6) 2011, product type catheter; product id 8598a, serial # (b)(4), implanted: (b)(6) 2014, product type catheter.(b)(4).

• 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): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4811980
• MDR Text Key: 5835867
• Report Number: 3004209178-2015-10091
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• 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: 05/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2012
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2015
• Date Device Manufactured: 01/27/2011
• 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: 00063 YR