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

Model Number 8637-40

Device Problems Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182); Application Program Problem (2880)

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

Event Date 06/25/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 8835, product type: programmer. If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was receiving 10 mg/ml of morphine at 7. 004 mg/day via an implantable pump for spinal pain. On (b)(6) 2020, it was reported that the patient's pump began alarming on (b)(6) 2020 because they missed their refill date. According to the patient, the alarm first started as a single-tone alarm sound on (b)(6)2020 and then changed to a dual-tone alarm that sounded like an ambulance on (b)(6) 2020. The pump was refilled and the alarm was resolved, but the patient's personal therapy management programmer (ptm) refill date did not updated when they had the pump refill. The refill date was still showing as their previous refill date. According to the patient, their next refill date was still showing as (b)(6) 2020 and their last refill date was showing as (b)(6) 2020. The patient reported that their most recent pump refill was done by the pharmacy ("ais") that was sent to the patient's home. The patient was not able to go to their clinic due to covid restrictions. The patient noted that their medication and dose/concentration had not changed and inquired about how to get the refill date updated. No symptoms were reported. No further complications were reported.

Manufacturer Narrative

Product id: 8835, serial# (b)(4), product type: programmer, patient. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer. The serial number of the ptm was reported. It was reported that the issue of the ptm displaying the wrong refill date was resolved after the patient talked to the hcp.

Manufacturer Narrative

Product id: 8835, product type: programmer, patient. If information is provided in the future, a supplemental report will be issued.

Event Description

On 2020-july-14, additional information was received from the patient that reported they were just at their hcp's office and the rep updated the refill date on their ptm.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10264145
• MDR Text Key: 198526506
• Report Number: 3004209178-2020-12030
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 05/05/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial