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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 Improper or Incorrect Procedure or Method (2017)
Patient Problems Overdose (1988); Complaint, Ill-Defined (2331); Sedation (2368)
Event Date 05/11/2018
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 healthcare provider (hcp) regarding a patient receiving morphine(25 mg/ml, 2. 5 mg/day) via an implantable infusion pump for the treatment of non-malignant pain. It was reported that 20 minutes prior to the call, a pocket fill occurred during pump refill. The amount of drug that went sub-q (subcutaneous) was unknown. The patient seemed more sedated so they started an iv(intravenous) and administered narcan. The patient "perked up" when the narcan was given. The patient is currently at the out-patient clinic and would be transferred to the hospital and monitor in-patient. The healthcare provider (hcp) would access the pump to see how much drug was in the reservoir. Refill kit is always utilized and it was unknown why the pocket fill occurred. This was considered a sudden change in therapy/symptoms. No further complication was 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 provider (hcp). It was reported that the patient was in the intensive care unit (icu) and was intubated. The patient weight was unknown, but the patient was noted to be "heavy. " 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 the food and drug administration (fda) and a healthcare provider. It was reported that the patient received an overdose of medication during a standard pump refill. It was determined that there may have been a malfunction of the device or there was a rare complication that occurred of pocket filling. The patient refused explant of the device to assist with further investigation of the pump.
 
Manufacturer Narrative
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 Key7510750
MDR Text Key108144816
Report Number3004209178-2018-10794
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 health professional,other
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2019
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/12/2017
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: 05/14/2018 Patient Sequence Number: 1
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