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

Model Number 8637-20

Device Problems Disconnection (1171); Filling Problem (1233); Material Integrity Problem (2978)

Patient Problem Headache, Lumbar Puncture (2186)

Event Date 09/05/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709, serial#: (b)(4), implanted: (b)(6) 2005, explanted: (b)(6) 2020, product type: catheter.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 08-jul-2006, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient receiving morphine 30mg/ml at 1.997mg/day via an implantable pump.The patient reported that they had been experiencing symptoms of "spinal block headaches" since early (b)(6) which was before their pump was replaced (b)(6) 2020 per the patient on (b)(6) 2020 the patient went in to get the 20 ml pump refilled but they could not find/hit the port, so they took her in for an x-ray in order to find it.Following that the patient went to have the surgery to have the pump replaced and they found that the catheter was "completely disconnected" from the pump.Per the patient, the physician stated the catheter "broke".

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10648122
• MDR Text Key: 210386042
• Report Number: 3004209178-2020-17497
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 10/08/2020
• Date Device Manufactured: 01/07/2014
• 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: 55 YR