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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 Problems Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017)
Patient Problems Arrhythmia (1721); Fall (1848); Headache (1880); Hypersensitivity/Allergic reaction (1907); Tinnitus (2103); Dizziness (2194); Ambulation Difficulties (2544); Cognitive Changes (2551); Insufficient Information (4580)
Event Date 05/14/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient who was receiving morphine of an unknown concentration at an unknown dose rate via an implantable pump for spinal pain. It was reported that the pump was implanted on (b)(6) 2021 and since then, when he woke up, the patient started having symptoms of severe headache, heart palpitations, ear ringing and light-headedness. It was noted that the patient was allergic to morphine but that is what was put in his pump. Hydromorphone was what was supposed to be in the pump. The patient had made an appointment with their physician who had told him that he would address the symptoms in two weeks. The patient was questioning if the a company representative could turn off the pump. Additional information was received via a consumer on (b)(6) 2021. It was noted that since implant the patient had a splitting headache that was due to the pump having the wrong medication in it. The patient does not react well to morphine. It was further noted that the pump they were shown was much smaller than what was implanted. The patient had visited their physician on (b)(6) 2021 was told their side effects were normal after implant. The patient had really bad pressure in her head and it felt like their "eyes and ears are going pop out". They also had a roaring headache and ringing in their ears. The patient was unstable and had fallen a few times because she was dizzy and unstable, lightheaded, and was having trouble with her balance. It was further described that their head was so messed up they can't keep track of anything. The patient had also requested the dimensions of the pump. The patient was redirected to their healthcare provider to address the issue.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11989305
MDR Text Key255973418
Report Number3004209178-2021-09277
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 Non-Healthcare Professional
Type of Report Initial
Report Date 06/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2022
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/05/2021
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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