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

Model Number 8637-40

Device Problems Kinked (1339); Migration or Expulsion of Device (1395)

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

Event Date 06/01/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, serial# (b)(4), implanted: (b)(6) 2010, product type: catheter. If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was receiving morphine (unknown concentration and dose) via an implantable pump. Indication for use was spinal pain. The date of the event was unknown. It was reported the patient had a couple of falls and either bent or dislodged the catheter. The pump was close to end of life and they decided to replace the pump as well. The issue was resolved. There was no out of box failure and no medical or therapy problem associated with small parts. No further complications were reported.

Manufacturer Narrative

Device codes (b)(4) and patient code (b)(6) are no longer applicable to the event. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp). The date of the event was approximately (b)(4) 2015. The bent or dislodged catheter was first noticed (b)(4) 2015 status post multiple falls and reported not sufficient pain relief. On (b)(4) 2015 a catheter dye study was done and unit was changed out completely (b)(4) 2015. The unit was not noted to be damaged or bent. A catheter dye study was done with ease, no difficulty. The patient was doing fine now with new unit. The patient¿s weight was noted as morbidly obese. Medical history was severe lumbar stenosis, lumbar degenerative disc disease (ddd) and lumbar radiculopathy.

• 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7472195
• MDR Text Key: 106863000
• Report Number: 3004209178-2018-09569
• 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

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/28/2011
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 12/08/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/30/2018 Patient Sequence Number: 1