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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 Pumping Stopped (1503)
Patient Problems Itching Sensation (1943); Muscular Rigidity (1968); Cramp(s) /Muscle Spasm(s) (4521); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/27/2022
Event Type  malfunction  
Event Description
Information was received from a healthcare provider (hcp) regarding a patient who was receiving lioresal (baclofen) (2000 mcg/ml at 1224 mcg/day) via an implantable pump for intractable spasticity.It was reported that the patient's pump stalled this morning on ((b)(6) 2022) at 8:52 am.The hcp confirmed that there has not been any environmental causes for the stall (no mri, emi, magnets).The hcp reported that they initially interrogated, waited another 20 minutes and interrogated again; however, it was still showing the motor stall message.No symptoms/patient complications were reported.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
 
Event Description
Additional information received from a saol therapeutics via a healthcare provider reported that, on (b)(6) 2022, seven days after receiving treatment with sl-1002/placebo, the patient experienced baclofen pump battery failure.There was a critical motor stall and drug was not being delivered.An x-ray of the thoracic spine and abdomen showed a right, lower quadrant baclofen pump with no evidence of intrathecal catheter kinking or discontinuity.The patient was admitted for baclofen withdrawal monitoring and pump replacement.The patient reported worsening spasticity in the afternoon which improved with baclofen 20 mg administered orally.Moderate increases in spasticity were treated with baclofen 10 mg orally twice a day and diazepam 2 mg orally three times a day for muscle spasms.The patient was treated with cyproheptadine 4 mg orally three times a day for itching.The subject denied pruritis, fevers, alteredmental status, irritability, or other baclofen withdrawal symptoms.On (b)(6) 2022, neurosurgery removed and replaced the baclofen pump without complications.Cyproheptadine was discontinued.On (b)(6) 2022, diazepam was discontinued.On (b)(6) 2022, the patient was discharged home in improved condition.Discharge medication included baclofen 10 mg orally three times daily as needed and tylenol (acetaminophen) 650 mg orally every 6 hours as needed.The event was resolved.
 
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Brand Name
SYNCHROMED II
Type of Device
PUMP, 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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key14581516
MDR Text Key301156799
Report Number3004209178-2022-07100
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169508156
UDI-Public00643169508156
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 Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/14/2018
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/27/2022
Initial Date FDA Received06/02/2022
Supplement Dates Manufacturer Received07/11/2022
Supplement Dates FDA Received07/14/2022
Date Device Manufactured09/15/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age64 YR
Patient SexMale
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