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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 Problem Premature End-of-Life Indicator (1480)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/19/2019
Event Type  Injury  
Manufacturer Narrative
(b)(6). 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 receiving ropivacaine [8. 0 mg/ml], sufenta [6 mcg/ml], prialt [4. 5 mcg/ml], and catapressan [10 mcg/ml] via an implantable pump. The doses were not reported. The indication for use was not reported. It was reported the pump was refilled correctly on (b)(6) 2019. On that date, the pump was in elective replacement indicator (eri), and the replacement date was calculated as (b)(6) 2019. On (b)(6) 2019, the critical alarm went off, and the patient went to the hospital. After interrogating the pump, the nurse saw that the pump already reached end of service (eos). The programmer read ¿terminal event has occurred in the pump ¿ eos occurred ¿ eri occurred ¿ schedule to replace the pump by (b)(6) 2019. ¿ early eos was suspected. The pump was implanted on (b)(6) 2016. Pump logs were not available. The patient did not experience any withdrawal symptoms. The pump was replaced and would be returned. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported that the programmed doses of ropivacaine [8. 0 mg/ml], sufenta [6 mcg/ml], prialt [4. 5 mcg/ml], and catapressan [10 mcg/ml] prior to eos occurring were 16 mg/24 hours, 12 mcg/24 hours, prialt 9 mcg/hours, and catapressan 20 mcg/hours respectively. It was also indicated that patient activated boluses were programmed as 1 mg of ropivacaine/0. 75 mcg sufenta/0. 56 mcg prialt/1. 25 mcg catapressan [calculated from the other bolus doses] with a maximum of 24/day. (b)(4) was used to interrogate the pump. It was noted that the hcp did not have any additional information to share.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Analysis determined the pump reached end of service (eos) based on the number of motor revolutions. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product id: 8870bbu01, serial# (b)(4), product type: software. Fdc updated for pump 8637-40, (b)(4). Fdm, fdr, and fdc apply for software card 8870, (b)(4). 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 Key8470004
MDR Text Key140498916
Report Number3004209178-2019-06394
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeFR
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 08/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2017
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/02/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/20/2016
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: 04/01/2019 Patient Sequence Number: 1
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