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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); Aspiration Issue (2883); Infusion or Flow Problem (2964)
Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial (b)(4), implanted: (b)(6) 2017, product type: catheter. The main component of the system. Other relevant device(s) are: product id: 8780, serial/lot (b)(4), ubd: 26-jul-2019, (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was provided by a consumer via a manufacturer¿s representative regarding an implantable intrathecal pump intended to deliver dilaudid [20 mg/ml] at 6. 001 mg/day and clonidine [250 mcg/ml] at 75. 02 mcg/day. The indication for use was unknown. It was reported that the patient experienced a return of pain symptoms. The event occurred in 2018; the patient was unsure of exactly when she noticed, and it was stated ¿at least a month ago, maybe before that. ¿ it was unknown if there were any environmental/external/patient factors that may have led or contributed to the issue. It was noted that the patient mentioned having back surgery in (b)(6) 2018. It was reported that at a pump refill on (b)(6) 2018, a discrepancy of over 6 ml was noted. At the refill on (b)(6) 2018, 19 ml were removed when 6. 6 ml had been expected. The patient had a myelogram on an unknown date, and the results reportedly showed the catheter tip in place. The patient presented for a dye study on (b)(6) 2018, and also scheduled a pump refill. It was reported that the physician could not aspirate from the cap and did not proceed with dye. The pump was filled and set to minimum rate. As an action/intervention taken to resolve the issue, the patient was referred for a catheter revision. The issue was not resolved at the time of the report. It was indicated that surgical intervention was planned but not yet scheduled. The patient's status at the time of the report was listed as ¿alive ¿ no injury. ¿ no further complications were reported. The patient¿s medical history was asked but unknown. Other medications the patient was taking at the time of the event could not be obtained as they were not available to the manufacturer.
 
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) via a manufacturer's representative on 2018-jun-12. It was indicated that the provided information was confirmed with the physician/account. Additional clarification was provided regarding the volume discrepancy seen at pump refill on (b)(6) 2018. The actual reservoir volume was greater than expected. Per the hcp's information, 15 mls were removed, and 8. 4 mls were expected. No further complications were reported.
 
Manufacturer Narrative
Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received on 2018-jul-05 from the manufacturer's representative. It was reported that the patient was scheduled for a catheter revision on (b)(6) 2018. The indication for use of the device was non-malignant pain. No further complications were reported.
 
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 Key7587319
MDR Text Key110627820
Report Number3004209178-2018-13085
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 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2019
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
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 Manufactured07/26/2017
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: 06/11/2018 Patient Sequence Number: 1
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