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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 8637-40
Device Problem Pumping Stopped (1503)
Patient Problems Fever (1858); Itching Sensation (1943); Muscular Rigidity (1968); Rash (2033); Diaphoresis (2452); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/10/2021
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 healthcare professional (hcp) regarding a patient receiving lioresal 2000 mcg/ml for a total dose of 875. 8 mcg/day via an implantable pump. It was reported on (b)(6) 2021 the patient tripped and fell landing on the pump site. The hcp stated after the fall the patient heard the pump alarming and when the pump status and logs were checked the pump had a motor stall which occurred at the same time as the fall. The hcp noted the pump was stalled for a couple days and recovered and then stalled again and recovered. It was noted the patient has some intrathecal baclofen withdrawal symptoms and has been taking oral baclofen. The hcp denied any electromagnetic imaging (emi) interaction and did not have a mri. Pump replacement and sending the pump back for analysis (if replaced) were discussed. The event date was (b)(6) 2021. Additional information received on (b)(6) 2021 stated the patient passed away yesterday ((b)(6) 2021) at home. It was noted the patient was taking oral baclofen and periactin for the withdrawal and had a scheduled appointment with the surgeon to replace the pump. It was noted the patient was having an autopsy and results were pending. It was discussed sending the pump back for analysis. Additional information received from a hcp on (b)(6) 2021 reported they were unsure if the patient¿s death was related to the device or therapy. The hcp related that the patient had fallen on the pump after tripping on some pillows on (b)(6) 2021. The patient¿s mother called the clinic on (b)(6) 2021 to report that the patient was experiencing itching, sweating, and increased tone; oral baclofen was started at that time. The patient was instructed to come in to the clinic for evaluation on (b)(6) 2021 and was evidenced to have increased tone, but no acute distress. Interrogation of the pump logs revealed motor stall on (b)(6) 2021, with recovery on (b)(6) 2021. A motor stall was again noted on (b)(6) 2021, with recovery on (b)(6) 2021. The pump was put to minimum rate (lowest allowable dose per concentration) during the clinic evaluation on 2021-nov-18 , oral baclofen and preactin were continued, and the patient was scheduled for a replacement consult on (b)(6) 2021. On (b)(6) 2021, the patient¿s mother called to report that the patient had passed away earlier that morning. The patient was fine and in no distress when they went to bed that night, but was found dead on the floor that morning. No autopsy was done as the patient was reported to have been embalmed and no device return is expected; analysis was declined and the patient was likely buried with the device. The coroner did take samples (blood and urine) for toxicology and was expected to coordinate with the clinic for review of records. The hcp stated that the patient¿s mother was to call them if they received additional information and that they would call us to update if any additional information is received either from the mother or if they are informed of toxicology results. No further information was 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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12973456
MDR Text Key286557878
Report Number3004209178-2021-18328
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 Other,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2017
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/31/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/22/2015
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: 12/09/2021 Patient Sequence Number: 1
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