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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 Pumping Stopped (1503); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182)
Patient Problems Pain (1994); Weakness (2145); Cramp(s) (2193); Therapeutic Response, Decreased (2271)
Event Date 10/11/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a health care provider (hcp) via a device manufacturer representative regarding a patient receiving an unknown drug at an unknown concentration and dose via an implantable infusion pump. The indication for use was noted to be non-malignant pain. It was reported that the patient complained of an increase in their pain. A refill was done on (b)(6) 2018 where 20 cc of drug was expected from the pump reservoir and 38cc was removed. The doctor did an in-office dye and rotor study. They were able to withdraw fluid from the catheter but they couldn't see the rotors move during the rotor study. There were no alarms or motor stalls noted by the doctor. The pump was planned to be replaced in (b)(6) 2018. There were no environmental, external or patient factors which may have led or contributed to the issue. The issue was not considered resolved. The patient's status at the time of the report was alive - no injury. 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 via a consumer. It was indicated that the pump had quit working / pump was not delivering the medication at it should. The patient experienced muscle cramps on (b)(6)2017. The patient¿s healthcare provider (hcp) had performed two refills and two withdrawals with the last one being on the 5th. It was further indicated that they had put in 40 ml of medication and withdrew 40 ml. When the pump was initially replaced they only put in the pain killer in the pump and left the muscle relaxer portion out of it. It was further indicated that on approximately(b)(6) 2017 the pump quit working and the patient experienced pain and withdrawal symptoms. On (b)(6)2017 they added the medication back in because he was having muscle cramps. The patient¿s pain was described jumping sky high. The patient ended up going back to a hospital on (b)(6)2017 and the pump was not working. The patient was so weak and was going through withdrawal symptoms. They sent the patient to the hospital by ambulance and they ended up sending him home stating he was just seeking more drugs. The patient ended up changing hcp's to do further tests on the pump. The patient also had an mri. At this point the hcp was looking into having pump replaced and the hcp was running this through the patient¿s insurance. The situation was being addressed by the hcp. The pump was currently administering dilaudid, baclofen, and another unknown drug. Drug concentrations and dose rates of each pump medication 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 consumer on 2018-jun-15. It was reported that the patient's doctor had been doing tests on the pump and determined that the pump was "completely not working. " the patient's doctor was trying to schedule a pump replacement but was having insurance issues. No further complications were reported.
 
Manufacturer Narrative
Analysis of the implantable infusion pump (b)(4) found no significant anomalies. 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
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 Key7494496
MDR Text Key107597279
Report Number3004209178-2018-10347
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,Followup,Followup
Report Date 09/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/14/2019
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2018
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? Yes
Date Device Manufactured08/17/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/08/2018 Patient Sequence Number: 1
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