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

Model Number 8637-20

Device Problems Failure To Service (1563); Device Displays Incorrect Message (2591)

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

Event Date 05/29/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) and consumer via a company representative regarding a patient receiving gablofen (500 mcg/ml at 99.98 mcg/day) via an implanted pump.The indication for pump use was multiple sclerosis and intractable spasticity.It was reported that the managing physician¿s office mistakenly did not schedule the patient for a pump refill in time and the low reservoir alarm went off on (b)(6) 2018.The patient resided in a nursing home and neither the nursing home or the patient heard the pump alarming for several days.They then called the managing physician¿s office (date and time not specified).The managing physician stated that after interrogating the pump, it was determined that the patient¿s pump had run dry and had been that way for several days.The patient was admitted to the hospital and placed on oral baclofen.The managing physician contacted the surgeon to emergently replace the patient¿s pump.The pump was replaced on (b)(6) 2018 and the catheter was aspirated and checked intraoperatively.Following the procedure, both the catheter and pump were working well.The issue was resolved.No patient symptoms were reported.The patient¿s status was reported as ¿alive ¿ no injury¿.The environmental, external, or patient factors that led or contributed to the event were noted to be that the managing physician¿s office failed to make an appropriate refill date prior to the low reservoir alarm date and the patient and nursing home failed to quickly notify the physician of the pump alarming.No further complications were reported/anticipated.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7605523
• MDR Text Key: 111191219
• Report Number: 3004209178-2018-13529
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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: Physician
• Type of Report: Initial
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2018
• Date Device Manufactured: 11/11/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 62 YR