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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 Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Pain (1994); Ambulation Difficulties (2544); Insufficient Information (4580)
Event Date 02/01/2019
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 receiving an unknown medication via an implanted pump. The indication for pump use was failed back surgery syndrome and non-malignant pain. It was reported that the patient went into withdrawal on saturday this past weekend. Per the patient¿s wife, ¿it picked up and corrected itself¿ and they were unsure why he was having these intermittent withdrawals. Ever since the pump was implanted in 2019, the patient had intermittent withdrawals. The patient would have back pain and he would taste metal when it occurred. At the last pump refill in (b)(6), they did a dye study which showed that the catheter was patent. Per the patient¿s wife, he did have some side effects from the dye study as they pushed morphine through the catheter. They felt he almost died, and it took him 15 minutes just to stand up after. The patient¿s wife believed that the pump had morphine and lidocaine but could not confirm this. Per the patient¿s wife, they had not heard the pump but her husband was hard of hearing so he may not have heard it. The patient was having a follow-up appointment with this doctor later this month and would have the doctor review the pump logs and call in to technical support for further considerations.
 
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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 Key13684845
MDR Text Key290060968
Report Number3004209178-2022-02883
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,Health Professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/14/2020
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Date Manufacturer Received05/24/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/18/2019
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: 03/07/2022 Patient Sequence Number: 1
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