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

Model Number 8637-20

Device Problems Filling Problem (1233); Increase in Pressure (1491); Insufficient Information (3190)

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

Event Date 05/01/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Additional information received from a manufacturer representative (confirmed via healthcare provider) indicated no further actions/ interventions were taken. It was clarified the health care provider (hcp) would like analysis performed if the pump was explanted. The cause of the reduced capacity was not confirmed to be due to the patient's scuba diving.

Manufacturer Narrative

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

Event Description

Information was initially received on (b)(4) 2017 from a healthcare provider (hcp) via a manufacturing representative regarding a patient receiving intrathecal baclofen 2000 mcg/ml at ¿500 something¿ mcg/day via an implantable pump for intractable spasticity and multiple sclerosis. It was reported that the hcp heard a popping sound as she refilled the patient's pump last week (from (b)(6) 2017). The date (b)(6) 2017 is considered an approximate date of event (month and year known only). This was the first time the sound was heard. They were not currently hearing the sound. The patient had not had any hyperbaric treatments. The patient did go diving, but states it was at the surface and also occurred months and months ago (from (b)(6) 2017). Since that time, the hcp had been able to fill the pump to capacity, including the refill last week (from (b)(6) 2017). The hcp requested to know if the sound would affect the infusion or circuitry of the pump. There were no reported symptoms. On (b)(6) 2017, additional information was received from a manufacturing representative. It was reported that no troubleshooting was performed, and technical services said ¿everything was fine. ¿ on (b)(6) 2017, additional information was received from a manufacturing representative. It was reported that no diagnostics were performed. The patient scuba diving was noted to be the cause of the popping sound. No actions/interventions were taken. The issue had not resolved. On (b)(6) 2018 additional information was received from a healthcare provider via a company representative. It was noted that the re was reduced capacity of the 20 ml pump. It was indicated that a physician assistant (pa) reported not being able to pump more than 12 ml of medication into the pump during routine refills. This had caused the patient to have to come in monthly for refills due to only having a partial refill. It was further noted that the healthcare provider¿s office reported that the pump had always produced a popping noise during refills. It was noted that this was reported a couple years ago to the manufacturer. The refilling issue started back in (b)(6) 2018 and it was indicated that the patient had admitted to also going scuba diving in august as well. The pump had displayed no alarms at this time and the expected residuals were correct during refills. The company representative had been notified of the issue on (b)(6) 2018 and had observed on (b)(6) 2018 (date of event) that the pump would not hold more then 12 ml of medication. No intervention was taken. The possible distortion of the pump¿s can, due to increased pressures during scuba diving, was being considered. It was indicated that the physician and patient were very concerned about proper pump operation due to the patient being on baclofen. They also had concerns about pump replacement as recommended by the manufacturer. No surgical intervention had occurred, and no surgical intervention was planned. The issue was not resolved at the time of the report. It was noted however that the hcp had requested analysis. The patient was without injury regarding their status at the time of the report. The pump was administering baclofen with concentration 2000 mcg/ml at a dose rate of 550 mcg/day. The drug lot number of baclofen was unknown. Other medications (oral, etc. ) the patient was taking at the time of the event was unable to be obtained. The patient¿s weight was provided. The patient¿s medical history included multiple sclerosis. No further patient complications have been reported as a result of this event.

• 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: 8010990
• MDR Text Key: 126085050
• Report Number: 3004209178-2018-24058
• 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,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/31/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/28/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 06/04/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial