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

Model Number 8637-20

Device Problems Filling Problem (1233); Difficult to Interrogate (1331); Unstable (1667)

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

Event Date 01/06/2014

Event Type  Injury  

Event Description

Additional information later reported the pump "was definitely flipped" and that the patient had reported on (b)(6) she "hit really hard into a chair" at site of the pump but they didn't know if that's what caused it to flipped.Per the reporter, the hcp ¿flipped it back¿ and they attempted to aspirate and couldn't get csf back flow so they may do a revision of the catheter.The managing hcp plans to do a dye study to check patency again before a revision is done.Additional information later reported the revision of the catheter was scheduled for (b)(6) 2014.

Event Description

It was reported, the managing hcp felt the patient's pump had flipped.The reporter had requested images of the pump to determine if the pump was flipped.Per the reporter, the image she had showed a/p view of the pump and showed the port was coming off the right side of the cap.The hcp had already sent patient back to the surgeon because he felt pump had flipped.Per the reporter, the hcp reported, he was hitting metal at the refill today.The hcp was doing the refill under fluoro.The hcp was going to fill pump with prialt but was unable to access so saline remains in the pump.Further information also reported the surgery was done (b)(6) 2013 and the patient had saline put in the pump.The patient came in the day of the report to have the saline removed and prialt put into the pump.This would be the first initial fill since the pump was implanted.The pump connector/catheter was coming off at around the 10 o'clock or 11 o'clock, with the cap at the 12 o'clock position.It was also noted they had trouble establishing telemetry with the pump.They had to palpate or move the pump around to establish telemetry.The patient is going to be seen on tuesday and the pump is going to be revised/flipped back on wednesday.They are going to refill the pump on thursday.Additional information later reported, the patient was to be seen by the implanting hcp on (b)(6).The pump was to be repositioned on (b)(6) and filled with prialt on thursday (b)(6).Additional information later reported, the repositioning was moved to (b)(6) and the refill date was to be determined.Additional information has been requested, but had not been received as of the date of this report.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Product id 8780, serial# (b)(4), implanted: 2013 (b)(6); product type catheter.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information later reported part of the old catheter was removed and the physician added the 8782 spinal revision kit.The patient's pump was filled (b)(6) 2014 with prialt.Before the pump fill the patient stated they had nausea and muscle spasms in her extremities since her revision surgery.Said she just didn't feel right.The patient also hadn't taken her vicodin which the hcp thought could be related to the nausea.It was further noted the patient had not followed up with her neurosurgeon.

• 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: 3588785
• MDR Text Key: 4088541
• Report Number: 3004209178-2014-01010
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2014
• Date Device Manufactured: 10/04/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 00045 YR