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

Model Number 8637-20

Device Problems Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182); Overfill (2404); Obstruction of Flow (2423); Infusion or Flow Problem (2964); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2018, information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient receiving baclofen (45 mcg/ml, 20.55 mcg/day), bupivacaine (35 mg/ml, 15.99 mg/day) and fentanyl (600 mcg/ml, 274.11 mcg/day) via an implantable pump for spinal pain.On (b)(6) 2018, the hcp was performing a refill and aspirated 17 ml of drug (arv) when there should have been 1 ml (erv).This was the patient's first refill after receiving a replacement pump on (b)(6) 2018.It was stated, "apparently patient was not experiencing any symptoms of withdrawal".There were no known environmental, external, or patient factors that may have led or contributed to the event.The hcp proceeded with refill.The patient was scheduled to return to the office on (b)(6) 2018 for the hcp to check the actual reservoir volume (arv) with the expected reservoir volume (erv).The issue was not resolved at the time of this report.No surgical intervention occurred nor was planned.The patient's status was alive - no injury.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

On 2018-july-26, additional information was received from an healthcare professional (hcp) via a manufacturer representative (rep).The patient had a check up on (b)(6) 2018 and the hcp reported there should have been around 15 ml of drug in the reservoir, but when he aspirated, there was a full 20 ml.A catheter study was scheduled for (b)(6) 2018.The cause of the volume discrepancy has not been identified.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product id: 8598a, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2018, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the consumer via a device manufacturer representative indicated that the catheter was revised and spliced several times and that it was determined that her catheter had a ¿hole¿.No further complications have been reported.

Manufacturer Narrative

Continuation of d11: product id 8598a, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2018 product type catheter h6; the device codes have been updated to include c63137, c63075 and c62897.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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

On 2018-july-27, additional information was received from the manufacturer representative (rep).It reported the dye study was comp leted on 2018-july-27 by the hcp.The hcp was unable to aspirate.After calculating the amount of drug the patient would receive, the hcp chose to push the drug through.The patient "had no effect", so the hcp pushed contrast and it was seen exiting at a pin connector in the back, "so drug is going into epidural space".The patient was scheduled for a catheter revision on (b)(6) 2018.The catheter would not be returned as the hcp chose not to remove the old catheter.

• 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: 7677637
• MDR Text Key: 114020805
• Report Number: 3004209178-2018-15478
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR