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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 Filling Problem (1233); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/11/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
On 2018-june-15, additional information was received from an healthcare professional (hcp). The patient's next refill was scheduled for (b)(6) 2018. The reported actions taken stated, "patient discharged from clinic in stable condition. As starter, follow-up appointment scheduled for 3 weeks prior to alarm date. Patient encouraged to go to nearest ed for any concerns/issues. Today is "post-procedure" day 4 and patient remains stable without any complications".
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
On (b)(6) 2018, information was received from a healthcare professional (hcp) regarding a patient receiving morphine (10 mg/ml, 2. 571 mg/day) via an implantable pump for spinal pain. On (b)(6) 2018, a volume discrepancy (actual reservoir volume (arv) less than expected reservoir volume (erv)) was discovered during a pump refill. The arv was 0 ml and the erv was 3. 66 ml. The hcp reported that they were not able to pull anything back from the pump. The hcp confirmed that they were using a medtronic refill kit. The hcp indicated that they had tried using multiple needles and they were under fluoroscopy during the refill so they were certain that they were in the pump reservoir. The hcp stated they have stuck the patient about 10-15 times and nothing came back. They tested to see if they were in the reservoir by injecting 5 ml of saline into the reservoir and when they pulled back, they were able to get all 5 ml back. The hcp stated that the pump had always been implanted deeply, so each time they refill the pump, it was a little more difficult. They also stated that this was the case with the previous pump as well. The hcp stated the pump would be refilled and the patient would be brought back in about 3 weeks earlier than normal to check the reservoir again. There were no reported symptoms.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
On (b)(4) 2018, additional information was received from the healthcare professional (hcp). It reported the patient came in for another refill and the clinic was still having problems aspirating the pump reservoir. The hcp stated they did do the refill under fluoro and were unsuccessful. The patient was on dilaudid (15 mg/ml, 2. 571 mg/day). The hcp requested a rep to come out and double check.
 
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
On (b)(4) 2018, additional information was received from the manufacturer representative (rep). The rep reported that the hcp was a ble to fill the pump with 5 cc of saline and withdraw 5 ccs of saline.
 
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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 Key7597739
MDR Text Key111733048
Report Number3004209178-2018-13345
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,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2018
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received09/06/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/08/2016
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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