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

Model Number 8637-20

Device Problems Migration or Expulsion of Device (1395); Material Integrity Problem (2978); Torn Material (3024)

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

Event Type  Injury  

Event Description

It was reported that the patient experienced a change to pain control, less than 50% therapy relief.An x-ray confirmed that the catheter migrated out of the intrathecal space for the third time.It was stated the bi-wing anchor was cut by ¿possibly¿ the suture (2-0 ethibond).During the revision, the catheter was found to be coiled by the anchor and completely out of the intrathecal space.The spinal segment was then replaced.The patient's status at the time of the event was stated to be alive with no injury.The pump was used to deliver fentanyl and bupivacaine.No outcome was reported regarding this event.Additional information could not be obtained at the time of the report.Should additional be received a supplemental report will be filed.

Manufacturer Narrative

Concomitant medical products: product id 8782, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2015, product type: catheter; product id 8835, serial# (b)(4), product type: programmer, patient; product id 8784, serial# (b)(4), implanted: (b)(6) 2014, product type: catheter.(b)(4).Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.

Manufacturer Narrative

Analysis of the catheter segment returned identified that the suture ring on the anchor was broken.

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.

• 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: 4508641
• MDR Text Key: 5536518
• Report Number: 3004209178-2015-02863
• 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,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2012
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2011
• 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): Required Intervention