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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 Insufficient Information (3190)
Patient Problems Bradycardia (1751); Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Hypothermia (1915); Overdose (1988); Vomiting (2144); Loss of consciousness (2418); Encephalitis (2429); Lethargy (2560); No Code Available (3191)
Event Date 07/24/2018
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a foreign health care provider (hcp) via a manufacturer representative regarding a patient who received unknown baclofen 2000. 0mcg/ml; 600. 3mcg/day in an implantable pump for an unknown indication for use. A patient death occurred. The hcp was "almost sure" the patient death was due to overdose. It was indicated a different hcp performed the last refill on (b)(6) 2018. Following the refill, the patient's condition became worse and the hcp (remote from moscow) tried to change the therapy. However, local hcps did not have a clinician programmer and the patient died at home. The patient's mother did not connect with a local neurologist or neurosurgeon. The programmer was checked and the dose was the same (the pump was explanted on (b)(6) 2018). The patient's mother and hcp were the "pump had problem with mechanism, because earlier patient reacted normally to dose. " the patient experienced hypothermia, decreased blood pressure to 70/50, "depression of consciousness. " the patient was treated with sirdalud and antidepressant. After the onset of symptoms the hcp excluded additional therapy and was going to come and change the baclofen dose. The provided interrogation session report was provided from the (b)(6) 2018 refill. The pump was explanted on (b)(6) 2018 and would be returned. It was reported the surgeon blamed the pump for the death. It was noted the low reservoir alarm occurred. At the time of interrogation the estimated reservoir volume was 2. 1ml with a low reservoir alarm volume of 3. 0ml (low reservoir alarm date of (b)(6) 2018; the logs were not read, the actual low reservoir alarm likely occurred prior to (b)(6) 2018). The patient lived with an adoptive family. The patient was vegetative after serious trauma and asphyxia. The pump was implanted approximately 2 years ago. The patient was on a high baclofen dose and additional therapy. No further information as provided.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a foreign health care provider (hcp) via manufacturer representative indicated on (b)(6) 2018, the patient's mother asked for advice because the patient became more sluggish, relaxed, and "lowering temperature below normal". The symptoms were initially associated with the use of the drug tizanidine (1mg/day). The drug was gradually removed with no change. The next week, the patient's mother contacted the hcp again indicating the patient was "still very bad". The patient slept all day and was vomiting. The patient's mother was given recommendations to consult with local doctors for examination (i. E. Ct/mri, eeg, blood tests). On (b)(6) 2018, the patient's mother phoned again as the patient was in serious condition. The patient's temperature dropped to 33. 8 degrees celsius, "food does not absorb", and the patient's eyes opened with difficulty. The patient was advised by a pediatrician who identified a "bad heartbeat" and mild breathing. All information was analyzed and it was suggested the patient may have an overdose of lioresal. The patient's mother was advised to go urgently to the hospital and arrange the arrival of a pump specialist to check the device and reduce the dose of lioresal. To the knowledge of the hcp, the pump was not examined for reasons unknown. The pump reservoir volumes were not checked at explant. The parents reportedly did not appeal to the hospital. On (b)(6) 2018, the hcp was notified by the mother about the patient's death. An autopsy was performed and the cause of death was reported as brain edema. The technology was not available to investigate the spinal fluid for baclofen concentration. Patient medical history included epilepsy, decreased level of consciousness, and dystonic attacks due to asphyxia. The patient also had a severe development delay. Following implant, the patient was discharged from the hospital to an orphanage. In the winter of 2018, the patient was taken into custody by a family from another city. Due to this, pump refills were performed by other physicians.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The returned pump was subjected to a series of standard tests that include but is not limited to visual inspection, alarm output, motor function, and dispense testing. The returned pump passed all testing in the laboratory and no anomalies were identified. 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 Key7898840
MDR Text Key121044572
Report Number3004209178-2018-21271
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeRS
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
Report Date 12/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2017
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/29/2016
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: 09/21/2018 Patient Sequence Number: 1
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