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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 Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Material Integrity Problem (2978)
Patient Problems Therapeutic Response, Decreased (2271); Underdose (2542)
Event Date 05/02/2018
Event Type  Injury  
Manufacturer Narrative
Product id: 8781, serial# unknown, product type: catheter. Other relevant device(s) are: product id: 8781, serial/lot #: unknown. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving baclofen [1000 mcg/ml] at a dose of 466. 8 mcg/day via an implantable pump for an unknown indication for use. It was reported on (b)(6) 2018 that the patient's therapy effect was unstable. The patient showed both underdose symptoms and good therapy effect. It was noted that the volume at the refill was more than the expected volume and that the hcp was planning a catheter revision. Logs were examined and attached with the report but did not show any significant events. No other diagnostics or troubleshooting was performed. There were no known environmental/external/patient factors that may have led or contributed to the issue. At the time of the report the issue was not resolved and the patient status was "alive - no injury" (note this is conflicting with the report of underdose symptoms. The patient's gender, age, weight, and medical history were asked but would not be made available. Other medications the patient was taking at the time of the event could not be obtained as they were not available to the manufacturer. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturer representative on (b)(4) 2018. It was confirmed that both the unstable therapy effect/underdose and the volume discrepancy were both first observed on (b)(4) 2018. The serial/lot number of the catheter and the implant dates for the catheter and pump were not available. A dye study would be planned soon. Details related to the revision were unknown as the physician wanted to plan only the dye study at the time of the report. It was indicated that the provided information had been confirmed with the hcp. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturer representative on 2018-jun-07. It was reported that the dye study was planned for the end of june. At the last refill the expected volume was 2. 3 ml and the aspirated volume was 12 ml. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received on 2018-jul-13. It was reported that the dye study was not yet performed and the revision was not yet planned. At the last refill the expected volume was 2. 7 ml and the effective volume was 14 ml.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported on (b)(6) 2018 that the dye study was still not planned but would probably be done in (b)(6).
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information reported that a dye study was not performed but a revision was performed on (b)(6) 2018. The physician noted a kinking and lesion on the pump segment near the pump connection; a photo of this was attached with the report. The physician replaced the pump segment and the patient was now receiving effective therapy and felt fine.
 
Manufacturer Narrative
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
Additional information was received. It was reported the explanted portion of the catheter pump segment would not be returned for analysis because it was discarded.
 
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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 Key7483029
MDR Text Key107221688
Report Number3004209178-2018-09964
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/14/2017
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 Received10/22/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/25/2015
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: 05/03/2018 Patient Sequence Number: 1
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