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

Model Number 8637-40

Device Problems Improper Flow or Infusion (2954); Insufficient Information (3190)

Patient Problems Muscle Weakness (1967); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Loss of consciousness (2418); Sleep Dysfunction (2517)

Event Date 01/23/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) via a company representative (rep) regarding a patient receiving an unknown intrathecal medication via an implanted pump for non-malignant pain.It was reported the patient did not feel like they were receiving the intended intrathecal drug.The event date was asked and unknown.It was noted there had been reservoir volume discrepancies, but it was unknown when that began.The rep that was present at the time of the implant stated the system was patent then.The rep was requesting catheter access port (cap) procedures and the rep would confer with the hcp.The rep did not know the weight of the patient at the time of the call.No further complications were reported.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

On 2019-aug-14, additional information was received from a manufacturer representative (rep).The rep reported the patient was at the an imaging place and had an magnetic resonance imaging (mri) performed.After the patient left the mri, the pump was beeping.Troubleshooting could not be performed due to lack of access to the product.No symptoms were reported.The patient was receiving morphine (25.0 mg/ml, 10.144 mg/day), marcaine (0.9 mg/ml, 0.365 mg/day) and clonidine (100 mcg/ml, 40.576 mcg/day).Information noted the morphine dose was 8.122 mg/day before an adjustment on monday.The rep mentioned that they did a dye study and roller study on monday because the patient felt the pump had not been working since mid-june.The catheter access port (cap) procedure showed the catheter was patent.The dose was increased and the hcp referred the patient to another hcp who requested the previously mentioned mri.The rep confirmed it had been less than 2 hours since the patient exited the mri field and that the patient roughly left the mri 45 minutes ago.

Manufacturer Narrative

Continuation of d11: product id 8780 lot# serial# (b)(6) implanted: explanted: (b)(6) product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8780 serial/lot# (b)(6), ubd 2020-12-08, udi# (b)(6)h6 ¿ conclusion code 67 is for the pump and conclusion code 22 is for the 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 on (b)(6) from the patient who reported that he only had the pump for 11.5 months; the medication was titrated down; and then the device system was explanted because he was feeling worse with the pump implanted than without it.He explained that he was getting symptoms that he never had before.He was passing out; experiencing ¿electric shots¿ going through his groin down to his leg; his legs felt so weak (¿like rubber¿); he was experienced withdrawals; and where the catheter was inserted in the l10 area of his body it felt like he was getting a knife stuck in his back.Per the patient, none of his medications worked including sleep medications.He only got 2 hours of sleep per night with sleeping pills and melatonin.He stated that he had to take even more medications in order to sleep and took a multivitamin and consumed energy drinks every day.He stated he was calling because he wanted to know when he would return to ¿normal¿ now that the pump had been removed.He stated that he had already spoken to his hcp (healthcare professional) and was told he shouldn¿t have had the pump taken out.He also stated that he could not drive that far due to the shape he was in.Physician listings were sent to the patient.The patient also mentioned during the call that his memory was going but gave the impression that this was unrelated to his devices or therapy.No further complications have been reported as a result of this event.

• 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: 8889314
• MDR Text Key: 154170764
• Report Number: 3004209178-2019-15544
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR