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

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Granuloma (1876); Pain (1994)

Event Date 02/10/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 8709, serial# (b)(4), implanted: (b)(6) 2005, explanted: (b)(6) 2017, product type: catheter.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

Information was received from a patient and the patient¿s wife via a manufacturer representative.The patient was receiving an unknown drug at an unknown concentration with an unknown daily dose via an implantable pump for non-malignant pain and post lumbar laminectomy syndrome.It was reported that the patient had a granuloma on the tip of their catheter.The patient had intense pain around their abdomen and midsection.The patient presented to the emergency room (er) on (b)(6) 2017 with intense pain.A magnetic resonance imaging (mri) scan showed something on the tip of the catheter.The pump and catheter were surgically removed on (b)(6) 2017.The pump and catheter were not replaced and would not be replaced in the future.The patient¿s medical history was asked but was unknown and the patient¿s concomitant medications were unable to be obtained by the manufacturer.It was unknown if the issue was resolved at the time of this report and the patient¿s status was stated as ¿alive ¿ with injury.¿ the patient¿s status after the explant procedure was unknown at the time of this report.The catheter would not be returned to the manufacturer because the customer discarded it.

Manufacturer Narrative

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): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6339853
• MDR Text Key: 67705671
• Report Number: 3004209178-2017-04096
• 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,consum
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2013
• 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: 02/13/2017
• Date Device Manufactured: 10/03/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1151-2008
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR