MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problems Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964)

Patient Problems Muscular Rigidity (1968); Diaphoresis (2452); Sleep Dysfunction (2517); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_cath, lot#: unknown implanted: (b)(6) 2020.Product type: catheter.Other relevant device(s) are: product id: neu_unknown_cath, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who w as receiving baclofen, unknown (2000ug/ml at 220ug/day) via an implantable pump for unknown indications for use.It was reported that at the patient¿s last refill, the actual reservoir volume (arv) was 9.2 ml, and the expected reservoir volume (erv) was 3 ml.The patient experienced signs of withdrawal (high tone, sweats, not sleeping).A myelogram was performed to check catheter function; they were unable to aspirate, so the myelogram was unsuccessful.The pump was checked for motor stalls, but nothing was detected.It was suspected that the catheter was the issue, but upon surgery to investigate, the catheter was found to be dripping cerebrospinal fluid (csf) when disconnected from the pump.When a new pump was attached, they were able to successfully aspirate.The clinician wished for the pump to be investigated for any potential issues.The device would be returned to the device manufacturer.It was unknown if the issue was resolved.The patient's status was alive - no injury.It was unknown when the event occurred.There were no environmental, external or patient factors that might have led or contributed to the event.Information regarding the patient¿s other medications was unavailable.

Manufacturer Narrative

Correction: annex f code f19 annex g codes g04105 and g04023 were inadvertently not included in the previous report.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

H3: 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 pump passed all testing in the laboratory and no anomalies were identified.H6: the previously applied method code b20 (4117) and results code c20 (3221) remains applicable to the catheter.The method code b01 (10) and results code c19 (213) pertains to the pump.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.

• 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
• MDR Report Key: 11864565
• MDR Text Key: 264858697
• Report Number: 3004209178-2021-08142
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2021
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2021
• Date Manufacturer Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR