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

Model Number 8637-40

Device Problems Insufficient Flow or Under Infusion (2182); Application Program Problem (2880)

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

Event Date 01/10/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8840, serial# unknown, product type: programmer, physician. If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a company representative regarding a patient who was receiving baclofen 2000 mcg/ml; 500 mcg via an implantable pump. Indication for use was intractable spasticity and spinal cord injury/spinal cord disease. The date of the event was (b)(6) 2019. It was reported a low reservoir alarm occurred on (b)(6) 2019, and an empty reservoir alarm occurred on (b)(6) 2019. No withdrawal symptoms were reported by the patient. The patient had impaired hearing, which may have contributed to him not hearing the low reservoir alarm which started on 1/10. The pump was refilled. The expected residual volume at time of refill on 1/15 was 0. 0 ml; the actual residual volume equaled 4. 0 ml. The volume discrepancy was documented and will continue to be noted at future refills. The low reservoir alarm date at the last refill on (b)(6) 2018, was (b)(6) 2019, but read as (b)(6) 2019, at the refill on (b)(6) 2019. It was reviewed that the alarm date will read as the current date if there is an active alarm. No diagnostics/troubleshooting were performed. Patient status was alive - no injury. The issue was resolved. Patient weight and medical history were asked but were unknown. No further complications were reported.

• 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: 8260113
• MDR Text Key: 133847736
• Report Number: 3004209178-2019-01271
• 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: 01/23/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• 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: 01/18/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 01/30/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial