MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
|
Back to Search Results |
|
Model Number 8637-20 |
Device Problems
Failure to Interrogate (1332); Inappropriate or Unexpected Reset (2959); Data Problem (3196)
|
Patient Problems
Muscular Rigidity (1968); Cramp(s) /Muscle Spasm(s) (4521); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/23/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Other relevant device(s) are: product id: a810, product type: software.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from a foreign healthcare provider via a manufacturer's representative (rep) regarding a patient who was receiving 2000 mcg/ml of compounded baclofen via an implantable pump.On 2021-mar-23, it was reported that the patient was at the hospital for severe spasticity and was severely spastic.The patient's pump showed service codes of 87 (safe mode), 101 (pump reset), and 197 (incomplete workflow-unchanged reservoir volume) when read.As a result of the pump being in safe mode, the pump was at a minimum rate of 12 mcg/day.The healthcare provider (hcp) was unable to reprogram or update the pump get it out of safe mode.The patient was transferred to a different hospital.The rep went and saw the patient on (b)(6) 2021.The hcp at the hospital also attempted to reprogram the pump to get it out of safe mode, but they were unsuccessful.Unsuccessful troubleshooting attempts included changing the low reservoir alarm volume, updating the reservoir volume, adding a note, switch from minimum rate to continuous rate with 440 mcg/day at 2000 mcg/ml.It was noted that the reservoir contained 6.2 ml when the rate was changed.The pump was emptied and then refilled with 20 ml of 3000 mcg/ml of baclofen.The pump programming was successfully updated with these changes using the old n'vision programmer, the delivery rate remaining at 440 mcg/day.It was noted that 3 different tablet programmers were used, but it was confirmed that reprogramming with the n'vision was successful and the issue was considered resolved.No environmental/external/patient factors that might have led or contributed to the issue were reported.No surgical intervention occurred or was planned.The patient's status was listed as "alive - no injury" and the rep noted that the patient and their guardian were happy.It was noted that the patient's last refill was on (b)(6) 2021 and the patient's next refill was planned for (b)(6) 2021.Additional information was received from the foreign healthcare provider (hcp) via the manufacturer's representative on 2021-apr-16.It was reported that the pump went into safe state while the pump was under normal interrogation for a refill.The patient¿s medical history included cerebral palsy.
|
|
Manufacturer Narrative
|
B3: corrected to reflect accurate event date 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.
|
|
Search Alerts/Recalls
|
|
|