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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 Insufficient Flow or Under Infusion (2182); Device Ingredient or Reagent Problem (2910)
Patient Problems Diarrhea (1811); Fatigue (1849); Seroma (2069); Vomiting (2144); Therapeutic Response, Decreased (2271); Sedation (2368)
Event Date 12/23/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) regarding a patient receiving gablofen (2000 mcg/ml at 861. 2 mcg/day) via an implanted pump. The indication for pump use was cerebral palsy. On (b)(6) 2020 it was reported that on (b)(6) 2019 the patient¿s pump was accessed and when they aspirated, they got back yellow discolored fluid from the pump. Per the hcp, the patient had had seromas in the past, but the hcp did not believe that the patient had a seroma that day. They were expecting 5 cc and got back 10 cc. The patient¿s build was small, and the pump was close to the surface. Four days ago ((b)(6) 2020), the patient started experiencing withdrawal symptoms and was brought to the er (emergency room) with diarrhea and vomiting. Yesterday ((b)(6) 2020), the pump was accessed and there were 0 cc in the pump just bubbles were removed, and it was hypothesized that a partial pocket fill could have occurred on (b)(6) 2019 but it was not certain. Patient symptom improvement, as of today ((b)(6) 2020), was not known as the patient was at home. No further complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received on (b)(6) 2020 from a healthcare professional (hcp) who reported that the volume filled and the volume programmed at the pump refill prior to (b)(6) 2019 was 20 ml. The cause for the volume discrepancy on (b)(6) 2019 and the cause for there being 0 cc (just bubbles) on (b)(6) 2020 had not been determined. The actions/interventions taken to resolve the volume discrepancies was noted to be that the pump was refilled on (b)(6) 2020 with 20 ml of 2000 mcg/ml medication. On (b)(6) 2020, the dose was decreased by 10% due to somnolence. On (b)(6) 2020 the dose was decreased again by 10% due to somnolence. Per the hcp, the pump remained implanted under close observation and they planned to access the reservoir tomorrow ((b)(6) 2020) if the patient remained sedate. No further complications have been reported as a result of this event.
 
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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 Key9641676
MDR Text Key176779273
Report Number3004209178-2020-02080
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
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/31/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2018
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 Received01/30/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/25/2017
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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