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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 Obstruction of Flow (2423)
Patient Problems Fatigue (1849); Overdose (1988); Urinary Retention (2119); Vomiting (2144); Complaint, Ill-Defined (2331); Sedation (2368)
Event Date 04/06/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, lot#: n596454002, serial#: (b)(4), implanted: (b)(6) 2016, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 24-nov-2017, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer via a healthcare provider (hcp) regarding a patient receiving intrathecal unknown baclofen (concentration and dose unknown) via an implanted pump for intractable spasticity and cerebral palsy, although, the hcp believed it was 2000 mcg/ml at 530 mcg/day. It was reported the caller was the attending on call hcp and received a call from the patient's mother stating the patient may be overdosed. The patient was "sleepy, and so sleepy he was having a hard time eating and has had vomiting episodes. " this began on (b)(6) 2020. It was noted the attending physician was in minneapolis, and the patient's mother said that they did not want to bring the patient down to minneapolis because of covid-19. The attending was wondering if there were any clinics in northern minnesota where the family lived that would be willing to program the pump dose down. The hcp confirmed the patient's last refill / programming was done (b)(6) 2020 and believed that the catheter had positional kinking, then when the patient was transferred, he received a bolus once the catheter unkinks. The hcp planned to call some physician's he knew and would call back if he needed further assistance. Additional information was received from the hcp on 2020-apr-15 indicated the patient¿s weight at the time of the event was unknown. The patient¿s last itb refill was (b)(6) 2020 and there was no change in dose. The patient experienced increased sedation, urinary retention, and decreased oral (po) intake. No further information or complications were reported.
 
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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 Key9969822
MDR Text Key194039326
Report Number3004209178-2020-07297
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 consumer,health professional
Reporter Occupation
Type of Report Initial
Report Date 04/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2017
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 Received04/07/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/16/2015
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: 04/16/2020 Patient Sequence Number: 1
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