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

Model Number 8637-40

Device Problems Filling Problem (1233); Kinked (1339); Material Integrity Problem (2978); Torn Material (3024)

Patient Problems Pain (1994); Seroma (2069); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Event Description

The patient had been implanted elsewhere approximately one year prior to this report.He had recently moved to the area, so limited information was known regarding his history.The patient reported only feeling good relief for about a month post-op.Ever since then, he reported return of pain/no therapeutic response.They were unable to access the pump at a refill attempt.It was determined via x-ray and physical exam that the pump was flipped.On the date of this report, the surgeon opened the pump pocket and found fluid in the pocket.The catheter was twisted in "100" knots; the catheter was sheared/broken where the catheter met the catheter connector.The physician felt that the pump had flipped several times causing the catheter to twist, knot, and break.The patient was obese and the pump was implanted low in the abdominal pannus which per the physician likely contributed to the flip or loosening sutures.The pump sutures were cut or torn through.When the back incision was opened, the spinal segment of the catheter was still intact and good csf (cerebrospinal fluid) back flow was observed.The pump segment of the catheter was ¿replaced, reconnected, re-tunneled and re-anchored¿.It was noted that the drug had been in the pump for over a year as the previous managing physician had not performed any refills.At the first post-op visit, they planned on changing the drug and starting at a lower concentration and dose.On (b)(6) 2015, the patient outcome was reported as ¿recovered without permanent impairment¿.The device system was delivering morphine.

Manufacturer Narrative

Concomitant products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2014, product type: catheter, product id: 8835, serial# (b)(4), product type: programmer, patient.(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: 4546375
• MDR Text Key: 16628906
• Report Number: 3004209178-2015-03650
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2015
• Date Device Manufactured: 02/21/2013
• 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