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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
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.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, 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 Key7578746
MDR Text Key110393897
Report Number3004209178-2018-12859
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
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 Received06/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/14/2019
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received05/29/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/22/2017
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
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