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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Incontinence (1928); Neurological Deficit/Dysfunction (1982); Loss of consciousness (2418); Test Result (2695)
Event Date 07/03/2018
Event Type  Injury  
Manufacturer Narrative
Occupation: healthcare professional (hcp). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) regarding a patient receiving intrathecal baclofen 2000 mcg/ml at 850 mcg/day via an implantable pump. The indication for use was not reported. It was reported that the patient was drowsy and unresponsive on (b)(6) 2018, and the patient was sent to the hospital. The patient was stabilized and felt better on (b)(6) 2018 and (b)(6) 2018. On (b)(6) 2018, the patient was unresponsive again and could not be awoken. The patient lost bladder control and had to be catheterized. The patient was intubated, and her blood pressure was dropping. The hcp accessed the reservoir, and there was no volume discrepancy. There was no pump alarm. The onset of the symptoms was sudden. The hcp was going to program the pump to minimum rate mode. The hcp plan on doing a dye study on (b)(6) 2018 with the neurosurgeon. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a foreign healthcare professional (hcp) via a manufacturer representative. It was reported the patient had severe dystonia following which her intrathecal baclofen (itb) was increased to 850mcg/day. She was on this dose for 2 weeks. However on (b)(6) 2018-, she became unresponsive and her glasgow coma scale (gcs) was reported to be 5. Her blood pressure was 70mm hg systolic. She remained like this for 12 hours, and then her gcs improved to 14 on its own and 5 hours later again dropped to 6 with hypotension. The hcp reduced the dose of itb from 850 mcg/day to 350 mcg/day following which she improved. She again had similar episodes of low gcs, but this lasted for only 5-6 hours. The patient had another episode last week (from (b)(6) 2018) when her itb was increased to 450 mcg/day. It was noted that ¿usually these episodes follows after a period of severe dystonia for 72-96 hours¿. It was noted that the patient¿s weight was ¿around (b)(6)¿.
 
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 MN 00777 1200
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos,pr MN 00777 1200
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7735087
MDR Text Key115554182
Report Number3007566237-2018-02269
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUK
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
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/28/2018
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 Manufactured10/10/2016
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: 07/31/2018 Patient Sequence Number: 1
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