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

Model Number 8637-20

Device Problems Difficult to Interrogate (1331); Device Displays Incorrect Message (2591); Application Program Problem (2880)

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

Event Date 09/06/2017

Event Type  malfunction  

Event Description

Information was received from a healthcare provider (hcp) on (b)(6) 2017 regarding a patient receiving unknown baclofen (2000mcg/ml at 247.1mcg/day) via an implanted infusion pump.The indications for use included intractable spasticity and multiple sclerosis.It was reported that the hcp was updating the patient's pump on (b)(6) 2017 and was having difficulty with telemetry.The patient was reportedly in a non-motorized wheel chair and the patient was holding the telemetry head.The telemetry was interrupted and the hcp saw a low reservoir and empty reservoir message.It was noted that telemetry was completed.The hcp then interrogated the pump, updated values, and completed another update.It was confirmed that all programming was accurate.No patient symptoms were reported and no further complications were reported or anticipated.

Manufacturer Narrative

The other relevant components include: product id 8840, (b)(4), product type: programmer, physician.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider on 2017-sep-11.It was reported that the issues occurred while they were updating the patient's pump with the low and empty reservoir alerts noted on the telemetry records on (b)(6) 2017 at 10:51.The hcp reported that the pump had 2.6ml residual volume at the time of update.The cause of the low/empty reservoir alarms was thought to be the result of the update being interrupted (which the hcp determined after speaking with technical services).The hcp noted that the patient was holding the telemetry head and believed that they were not holding it correctly, which resulted in the difficulty completing telemetry.The pump was interrogated several times, both during the actual update and then again 40 minutes afterward before the hcp left the patient's house.Everything appeared correct.The low/empty reservoir alarms were considered resolved because at the second interrogation, the settings appeared current and no issues were noted.No alarms were heard by the patient.The patient reportedly had no complaints as of 2017-sep-06.

• 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: 6848005
• MDR Text Key: 85123355
• Report Number: 3004209178-2017-18876
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2017
• 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: 09/11/2017
• Date Device Manufactured: 01/28/2016
• 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 Age: 61 YR
• Patient Weight: 82