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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 Insufficient Information (3190)
Patient Problems Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Overdose (1988); No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) via a manufacturer¿s representative (rep) regarding the patient¿s implantable drug infusion device. The drug being delivered was baclofen (unknown) with an unknown dose and concentration. The reason for use was not reported. It was reported that the ¿catheter needs repair/replacement. ¿ it was unknown if there were any environmental/external/patient factors that may have led or contributed to the issue. It was unknown if there were any diagnostics/troubleshooting performed. It was unknown what interventions/actions were taken to resolve the issue. The issue was not resolved at the time of the report and the patient status was listed as ¿alive ¿ no injury. ¿ the patient is scheduled for a catheter revision/replacement on (b)(6) 2018. There were no further complications reported/anticipated.
 
Manufacturer Narrative
Continuation of d11: product id 8709sc lot# n144298011 serial# implanted: 2008-(b)(6)explanted: 2018-(b)(6) product type catheter h3 ¿ patient code (b)(4) is no longer applicable for this event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received on 31-oct-2018 from a healthcare professional (hcp) who reported that the patient¿s catheter was replaced on (b)(6)-2018. Before the surgery, the patient was receiving gablofen (2000 mcg/ml at 1300 mcg/day). After the surgery, the pump dose was decreased to 650 mcg/day. In the afternoon, the patient went into overdose with symptoms of somnolence and blood pressure dropping. They reduced the pump to minimum rate (11. 9 mcg/day). On (b)(6) 2018 the patient was doing fine, so they programmed the pump to a therapeutic rate of 100 mcg/day. The indication for pump use was cerebral palsy and intractable spasticity. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the hcp via the rep on 2018-oct-31. The physician¿s nurse reports that the patient had received too much baclofen post-op and was placed in the icu. The pump was placed on minimum flow rate. There were no further complications reported/anticipated.
 
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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 Key8009418
MDR Text Key125147375
Report Number3004209178-2018-24004
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,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2016
Device Model Number8637-40
Device Catalogue Number8637-40
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 Received10/31/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/16/2014
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: 10/26/2018 Patient Sequence Number: 1
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