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

Model Number 8637-40

Device Problem Application Program Problem (2880)

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

Event Date 01/17/2013

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, serial# (b)(4), implanted: (b)(6) 2011, product type: catheter.Product id: 8835, serial# (b)(4), product type: programmer, patient.(b)(4).

Event Description

The patient had an mri of his knee.The pump was interrogated approximately 30-45 minutes after the patient got out of the mri.There was no motor stall recorded in the event logs.The pump had not been turned off prior to the mri.The patient was asymptomatic.The plan was to send the patient home.The device system was delivering bupivacaine and dilaudid.

• 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: 4935994
• MDR Text Key: 22722831
• Report Number: 3004209178-2015-13990
• 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: company representative
• Reporter Occupation: Other
• Report Date: 01/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2012
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2013
• Date Device Manufactured: 04/06/2011
• 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 Age: 00042 YR