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

Model Number 8637-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cerebrospinal Fluid Leakage (1772); Headache (1880); Seroma (2069); Pressure Sores (2326); Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 02/27/2023

Event Type  Injury  

Event Description

Information was received from a consumer regarding a patient receiving intrathecal saline via an implanted pump.The patient¿s indication for use was non-malignant pain.It was reported 'within three days of implant, i had a headache (later positional headache) that did not go away for three weeks.I couldn't stand for more than a minute.A few days after, i was touching where the pump was implanted, and it felt like a tick tack was moving on top of the pump¿.It was reported the patient could feel it and got a bedsore.On (b)(6) 2023 , they decided to remove the pump due to the bedsore.It was noted the pump was implanted in the patient¿s behind instead of abdomen, and maybe that was why ¿i got the ulcer¿.It was noted ¿he was not able to make the pocket deep enough, or did not want to, i don't know¿.It was reported the hcp did not find a spinal fluid leak and told the patient¿s husband that when he took the catheter out, he put in extra blood in between something instead of doing a blood patch.Hetold the patient¿s husband ¿it wasn't a blood patch, but i don't know what it actually was¿.When he went to take it out, there was no saline left in the pump, but it was dripping down the patient¿s leg and there was a pocket of fluid where it was implanted.The patient did not know if what was dripping was spinal fluid or the saline.The patient¿s assumption was that it was spinal fluid coming out of the ulcer.The patient wanted answers and ¿he wasn't happy it had to be explanted¿.The patient inquired, ¿what if fentanyl was put in there, wouldn't there be lots of problems?¿ the patient was redirected to the healthcare provider (hcp).The patient also reported ¿i still have a headache and i'm going to lay down for a few days.¿ the confirmed pump and catheter were both explanted on (b)(6) 2023.

Manufacturer Narrative

Concomitant medical products:¿ product id 8780 lot# serial# hg6t16d19 implanted: (b)(6) 2023 ,explanted: (b)(6) 2023 , product type catheter information references the main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: hg6t16d19, ubd: 20-jan-2025, udi#: (b)(4).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

Continuation of d10: product id 8780 lot# serial# (b)(6) implanted: 2023-02-27 explanted: 2023-03-20 product type catheter 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.

Event Description

Additional information was received from a healthcare provider (hcp) and patient (con) that reported the patient requested to have the pump and catheter removed.The patient had a csf leak around the catheter.The patient was lying in bed that caused the bed sore ulcer.It was in the area of the pump, but not communicating with it.The hcp noted hopefully the csf leak had resolved.The device was left at the surgery center.

• 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 Key: 16624712
• MDR Text Key: 312099330
• Report Number: 3004209178-2023-04107
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000634094
• UDI-Public: 00763000634094
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2023
• Date Device Manufactured: 01/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 88 KG