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); Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Nausea (1970); Overdose (1988); Vomiting (2144); Dizziness (2194); Therapeutic Response, Decreased (2271)

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 company representative regarding a patient with an implantable pump for non-malignant pain.The pump was currently administering the following mediations: clonidine (concentration: 148 mcg/ml, dose rate 28.07 mcg/day), bupivacaine (concentration: 16.6 mg/ml, dose rate: 3.149 mg/day), and dilaudid (concentration: 2.3 mg/ml, dose rate: 0.4363 mg/day; primary).It was reported that a pump volume discrepancy occurred regarding the actual reservoir volume (arv) having been less then the expected reservoir volume (erv).The patient was in for a pump refill on (b)(6) 2019 and was performed by a nurse.It was noted that arv was 0 and erv was 3.The nurse believed there was a leak in the pump.The nurse then filled the pump with 10 cc of saline and pulled out 10 cc of saline.The nurse then decided to fill the pump with the prescribed medication and informed the managing physician to perform a dye study based off the volume discrepancy.Immediately following the refill, the patient became dizzy, nauseous, and began vomiting for 12 hours.It was further noted that the patient fell after the (b)(6) 2019 refill due to dizziness.The patient thought this was withdrawal symptoms.It was further indicated that at the previous refill (the date of refill/event was unknown), there was also a volume discrepancy noted and the patient experienced these same symptoms immediately following the refill.The volume discrepancies noticed at this previous refill were in the same range as the ones observed on (b)(6) 2019.Regarding troubleshooting performed prior to the report/call, it was indicated that the reservoir was accessed.Monitoring the patient, filling the pump half full, bringing the patient back early to check volume, and performing imaging to assure there was not a pocket fill was being considered.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

The initial reporter and contact information has been updated regarding additional information received.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a company representative.It was clarified that the patient initially reported the event to the company representative.The logs were read and there were no motor stalls or new events seen since the refill performed on (b)(6) 2019.It was noted as being unknown if it was confirmed that the needle was fully inserted into the refill septum at the time of the refills.Fluoroscopy/imaging was not performed at the time of the refills in question.A leak was not confirmed.The cause of the issue/pump believed to be leaking, volume discrepancy, withdrawal symptoms, dizziness, vomiting, and nausea was not determined/confirmed.The plan moving forward was to have the patient come into the office before her next refill in approximately two weeks for a check on reservoir volume.The next refill was to be performed by the physician at their office.It was further noted that the patient was also directed to their primary care physician for evaluation and her blood pressure was checked.The issue/pump believed to be leaking, volume discrepancy, withdrawal symptoms, dizziness, vomiting, and nausea was not resolved at this time.The patient had reported feeling dizzy on (b)(6) 2019.The patient¿s weight at the time of the event was to be determined.The catheter and pump remained implanted at this time.The company representative indicated that they had confirmed the provided information with the physician/account.

Manufacturer Narrative

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

Manufacturer Narrative

Update: the type of report has been update from previously being a reportable malfunction to now a reportable serious injury.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received form a healthcare provider via a company representative.The company representative indicated that a call came in (b)(6) 2019 reporting that the patient was in the intensive care unit (icu) and they believed the patient was either in withdrawal or overdose (od).The patient¿s managing hcp had visited the patient in the icu and had pulled out 11 ml when they were expecting 17 ml.They had turned the pump to a minimum rate at this time and they planned to replace the pump tomorrow.As per the manufacturer¿s device registry, the pump was replaced on (b)(6) 2019.The company representative did not know if there were any falls or traumas and did not believe the patient has had any heat therapies.Keeping the pump at minimum rate or if they should turn off the pump was being considered.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8888602
• MDR Text Key: 154161598
• Report Number: 3004209178-2019-15522
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/30/2019

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: 01/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2019
• Date Device Manufactured: 07/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1570-2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention