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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 Device Operates Differently Than Expected (2913)
Patient Problems Abdominal Pain (1685); Headache (1880); Nausea (1970); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Anxiety (2328); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517)
Event Date 10/07/2017
Event Type  malfunction  
Event Description
Information was received from a patient who was receiving 12. 3 mg/ml of bupivacaine at 4. 136 mg/day and 11. 3 mg/ml of dilaudid at 3. 8 mg/day via an implantable pump for spinal pain. On (b)(6) 2017, it was reported that the patient's pump malfunctioned on (b)(6) 2017 and they went through withdrawal. According to the patient, they experienced normal withdrawal symptoms of funny smells, funny tastes, restless sleep, being unable to sleep, stomach ache, headaches, nausea, and nervousness. The patient stated that it was an "all over horrible feeling". The patient went to the er on (b)(6) 2017. The er reportedly gave the patient's "shots" and sent the patient home. The patient noted that they had requested the er not do this as "it would happen again". The patient was, at the time of the report, in pain and reported "it happened again". The patient reported that the pump was not working and malfunctioning and speculated that there may be a kink in it. The patient's healthcare provider (hcp) was unable to see the patient at that time and recommended that the patient return to the er to have a manufacturer's representative (rep) read the pump and perform a dye study. The patient later reported that the er wasn't able to "get it done" and requested a rep see them. The patient also requested a list of healthcare providers who could put the patient in the hospital. 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 Key6991839
MDR Text Key91909184
Report Number3004209178-2017-22887
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 consumer
Reporter Occupation
Type of Report Initial
Report Date 10/31/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2018
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/20/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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