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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 Difficult to Advance (2920); Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 05-dec-2005, udi#: (b)(4); product id: 8596sc, serial/lot #: (b)(4), ubd: 17-may-2009, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) via a company representative regarding a patient who was receiving an unknown medication via an implantable pump. Indication for use was non-malignant pain. The date of the event was unknown. It was reported that the healthcare provider (hcp) was doing a catheter access port (cap) dye study and was unable to aspirate form the cap. The hcp then pushed the dye thru the cap and catheter and saw a spread of dye on x-ray. No symptoms were reported. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare professional (hcp) via a company representative. The inability to aspirate the catheter access port occurred (b)(6) 2019 (date unknown). Surgery was performed on (b)(6) 2019 to replace the catheter. The physician had to explant the entire system and could not get a new catheter in. The cause of the inability to aspirate the catheter access port was not determined. The inability to aspirate the catheter access port has been resolved as the system was explanted. The patient¿s weight at the time of the event was unknown.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare professional (hcp) via a company representative. The patient¿s spine was very difficult, and the doctor couldn't get the catheter in the intrathecal space. The catheter will be returned. The pump was delivering dilaudid 2. 5 mg per ml; 0. 65 mg per day and bupivicaine 2. 5 mg per ml; 0. 65 mg per day.
 
Manufacturer Narrative
The catheters were returned and analysis found no significant anomaly. If information is provided in the future, a supplemental report will be issued.
 
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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
MDR Report Key8300912
MDR Text Key134909710
Report Number3004209178-2019-02312
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup
Report Date 04/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2019
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/04/2019 Patient Sequence Number: 1
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