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

Model Number 8637-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Fever (1858); Itching Sensation (1943); Muscle Spasm(s) (1966); Muscular Rigidity (1968); Overdose (1988); Therapeutic Response, Decreased (2271); Loss of consciousness (2418); Neck Pain (2433)

Event Date 05/24/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8596sc, serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: catheter product id: 8703w, serial# (b)(4), implanted: (b)(6) 1997, explanted: (b)(6) 2018, product type: catheter. If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via manufacturer representative (rep) regarding a patient who was receiving compounded baclofen, 2000 mcg/ml concentration at 130 mcg/day dose, morphine, 27 mg/ml concentration at 1,753 mg/day and clonidine, 2000 mcg/ml concentration at 130 mcg/ml dose via intrathecal drug delivery pump for unknown indication of use. It was reported that patient was at hcp's office for a routine pump refill on (b)(6). Refill was done under us guidance without issues. Patient had allergy to chloraprep and they used chloraprep by accident so kept patient in the waiting room for 30 minute to monitor. Patient became unresponsive and had difficulty breathing. The hcp shut pump off. Emergency medical service was called. Narcan and cardiopulmonary resuscitation (cpr) administered. Patient was taken to emergency room and admitted. The hcp went to the hospital to see patient approximately 2 1/2 hours later and patient then appeared to be in acute baclofen withdrawal- rebound spasms/spasticity, itchy. Patient was sent to intensive care unit (icu), started on oral baclofen and iv lorazepam. On (b)(6) patient developed fever and neck pain and they were questioning meningitis. Pump/catheter were explanted on (b)(6). For environmental/external/patient factors that may have led or contributed to the issue were that the hcp reported no issues during refill. Us guidance confirmed needle in the pump port. It was unknown if the issue had been resolved at the time of this report and patient status was alive- no injury. No further complications were reported. Additional information was received from a healthcare professional (hcp) via the manufacturer representative (rep). It was reported that the cause of overdose/underdose was not determined. Narcan was administered for overdose. Patient was started on oral baclofen and iv lorazepam for underdose. Per the hcp on (b)(6)- "withdrawal over. Very complicated hospital course with new infection. Comfortable without pump. " the device was disposed of by the hospital. No further complications were reported. Additional information was received from a healthcare professional (hcp) via the manufacturer representative (rep). It was reported that meningitis was ruled out. Patient had cellulitis. 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: 7578746
• MDR Text Key: 110393897
• Report Number: 3004209178-2018-12859
• 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
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 02/14/2019
• 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: 05/29/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 08/22/2017
• 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: 06/07/2018 Patient Sequence Number: 1