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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 Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bradycardia (1751); Fatigue (1849); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914)
Event Date 10/19/2018
Event Type  Injury  
Manufacturer Narrative
(b)(6). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a foreign healthcare professional (hcp) via a study regarding a patient receiving intrathecal clonidine 200. 0 mcg/ml at 200. 0 mcg/day via an implantable pump. Conflicting information indicated the concentration was 1200 mcg/ml. The indication for use was not reported. It was reported that 30 minutes after the pump was refilled, the patient felt sleepy. The patient experienced high tension and bradycardia. The hcp stopped the pump, and the patient was seen in intensive care. The pump was refilled again; the pump was missing 4ml. The pump was started again at the same flow; the patient had clonidine ¿1200 mcg/ml¿ 200 mcg/day. The patient went home and slept very well. No further complications were reported. Additional information was received. It was reported that the event resolved without sequelae (b)(6) 2018. It was reported that after the refill the patient slept and it was difficult to ¿awake¿. It was reported that the patient stayed a night in intensive care. It was reported that the reported event was related to the device or therapy. It was reported that the pump was programmed with 15 bolus of 28 mcg with a lockout of 1 hour. No further complications were reported and/or anticipated.
 
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
When asked for the cause of the 4 ml volume discrepancy and symptoms following refill, the site replied, "yes because 4ml misses this 4ml gave him this symptômes. " when asked if "4 ml misses" meant that 4 ml was injected into the pocket, the site again replied, "yes because 4ml misses this 4ml gave him this symptômes. ".
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from an hcp. A filling of the intrathecal pump was performing according to the protocol in force; this was done under ultrasound to identify the filling site. After 45 minutes, the patient became drowsy and had high blood pressure. The risk for the patient was described as a hemodynamic impact on the patient as well as hospitalization. Precautionary measures included a call from the head doctor and placement of a venous line on the patient. It was stated the "patient falls asleep," but could be woken up by the sound of voice. The patient was put on oxygen. The patient experienced bradycardia. The pump was stopped, and the patient was transferred to the intensive care unit (icu). The patient was treated for the low blood pressure and low heart rate. It was reported the "pump is empty: 4 cc of the 40 cc is missing, i. E. 4800 mcg around the pump (the patient receives 620 mcg of clonidine intrathecally /day). " the pump was refilled and restarted. The patient was under supervision until the following day, the date on which they left the ward.
 
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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 Key8038262
MDR Text Key126117470
Report Number3004209178-2018-24663
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 12/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2017
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/16/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1060-2011

Patient Treatment Data
Date Received: 11/05/2018 Patient Sequence Number: 1
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