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); Unstable (1667)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/23/2013

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8731sc, serial# (b)(4), implanted: (b)(6) 2013, product type: catheter.Product id: 8835, serial# (b)(4), product type: programmer, patient.(b)(4).

Event Description

Since (b)(6) 2014, the pump was upside down; the pump was not attached.At every refill, the pump needed to be flipped.The pump was being refilled every month; the patient was told it would be filled every few months.There were no plans for surgery at this point.The device system was delivering morphine; clonidine and baclofen were added later.The interventions were not reported.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a consumer regarding a patient who received clonidine (100.0mcg/ml, 0.50mcg/day), marcaine (0.9mg/ml, 0.00540mg/day), and unknown morphine (25.0mg/ml, unknown dose) in an implantable pump for spinal pain indicated the pump flipped on (b)(6) 2013.The patient was told by the healthcare provider (hcp) to leave the pump alone if the patient did not experience any issues.The hcp would flip the pump over to refill while the nurse held the pump.This creates an issue with communication; had to move the personal therapy manager (ptm) around and reposition it to get a bolus.The patient was still getting pump medication adjustments regarding her pre-existing pain needs from multiple sclerosis.The situation was currently being addressed by their hcp.

• 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: 4931154
• MDR Text Key: 22648025
• Report Number: 3004209178-2015-13823
• 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: Other
• Type of Report: Followup
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2014
• 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: 06/30/2016
• Date Device Manufactured: 02/28/2013
• 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 Age: 00047 YR