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

Model Number 8637-40

Device Problems No Audible Alarm (1019); Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Pain (1994); Therapeutic Response, Decreased (2271); Discomfort (2330); Sleep Dysfunction (2517)

Event Date 01/01/2019

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 consumer regarding a patient who was receiving clonidine and dilaudid at unknown doses and concentrations via intrathecal drug delivery pump. The indication for use was noted as spinal pain. It was reported that there was an error made with the last refill on (b)(6) 2018, in that there was only enough medication for 45 days rather than the standard 90 days, however the patient was not notified of this. She had moved to (b)(6) however was planning to keep going back to (b)(6) for refills. She had a bad fall on (b)(6) 2019 and shattered her right leg, was hospitalized, and had an extensive surgery so she could not travel to get back for refill. She was scheduled for her next refill on (b)(6) 2019 and she called the healthcare provider (hcp) office and this was when she was notified that her pump was not filled with 90 days of medication. She did not know if the office staff even notified the hcp. She was still on bedrest and could not travel. The patient made arrangements with a home infusion agency, however they called her back and said that because the pump had been dry, the patient had to see the hcp first and run some testing. The patient had increase in pain in lower back and legs. It was a gradual change in symptoms. After speaking with the hcp office, the patient checked the pump with the personal therapy manager (ptm) and she saw a picture of an alarm and date of (b)(6) 2019. She never heard an alarm. On (b)(6) 2019, the patient had difficulty sleeping. On (b)(6) 2019, the patient was uncomfortable during the day, pain returned, and they were again having difficulty sleeping and started sleepwalking and that was when the patient fell and shattered her leg. No interventions were mentioned. The patient was trying to find a local hcp to assist in the situation. She had not heard from the managing hcp in (b)(6). There were no further complications reported at this time.

• 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: 8347824
• MDR Text Key: 136492432
• Report Number: 3004209178-2019-03415
• 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
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/14/2017
• 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: 11/10/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 05/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/18/2019 Patient Sequence Number: 1