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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 Device Operates Differently Than Expected (2913)
Patient Problems Chest Pain (1776); Dyspnea (1816); Vertigo (2134); Dizziness (2194)
Event Date 05/01/2018
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 consumer via a device manufacturer representative regarding a patient receiving an unknown drug via an implantable infusion pump. The indication for use was post lumbar laminectomy syndrome and non-malignant pain. It was reported that for a couple of months the patient has had symptoms of dizziness, vertigo, chest pain, shortness of breath, and the symptoms were reported to come and go. The caller stated that the patient had been to the emergency room and was told by healthcare provider (hcp)'s that it¿s the pump causing the adverse symptoms. Pump recall information was found by the patient and he inquired if his pump was affected; his pump battery is not affected by the recall. No further complications have been reported as a result of this event.
 
Manufacturer Narrative
Review of this mdr and additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report had malfunctioned. Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider indicated that there was no device malfunction. The pump logs were read and normal, the pump was refilled, and pain was controlled. It was reported that the patient's symptoms were believed to be related to a hormonal imbalance, lab results were pending. The patient's weight at the time of the event was reported. No further complications have been reported as a result of this event. Mdr decision corrected to not reportable. No additional supplementals required unless additional information received indicates reportable event.
 
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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 Key7658015
MDR Text Key113003261
Report Number3004209178-2018-14857
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,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2017
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received07/05/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/12/2016
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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