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

Model Number 8637-40

Device Problems No Audible Alarm (1019); Failure To Service (1563); Volume Accuracy Problem (1675); Device Displays Incorrect Message (2591)

Patient Problems Therapeutic Response, Decreased (2271); Malaise (2359); Sweating (2444)

Event Date 01/01/2018

Event Type  malfunction  

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) regarding a patient receiving intrathecal dilaudid 5 mg/ml at 1.5 mg/day via an implanted pump for non-malignant pain.The patient called the hcp with drug infusion issues and was on her way to the clinic.An alarm was heard but was not confirmed by telemetry.The hcp had intrathecal (it) meds to fill the pump on the date of this report.It was noted with the last telemetry, (b)(6) 2018 was the low reservoir alarm date.The patient reported she heard the critical pump alarm that began a couple of days ago (maybe (b)(6) 2018), but never heard the non-critical alarm (event date prior to the critical alarm, but basically the same time frame of (b)(6) 2018).The patient started to experience withdrawal symptoms that began at around noon on the date of this report along with excessive sweating and starting to not feel good.It was also reported the patient had been experiencing personal therapy manager (ptm) issues with changing batteries weekly and the low reservoir alarm date changing abnormally ((b)(6) 2018 but then changing again to (b)(6) 2018 when turning the ptm off and on again).The screen was going blank/shutting off when it was telemetered with the pump according to the patient.The hcp was not sure what batteries the patient was utilizing for the ptm.The provider was told about the ptm issues (b)(6) 2018 which was the last office visit and it was going on before that (specific date not reported, 2018).The hcp recommended the patient utilize the ptm to see if there was a code, but because the ptm shut off automatically it did not stay on long enough to be able to see if there was an alarm code.(b)(6) 2018 was the last pump refill.Additional information was received from the hcp on the same day indicated the power issue with the ptm was fixed by replacing the batteries.The patient came to the office and when they interrogated the pump it showed an empty reservoir alarm.It was noted based on the problem the patient had with the ptm she thought she had more time before a refill and at one point she stated the ptm showed an alarm date of (b)(6) 2018.The patient claimed she had not used the ptm for two weeks.Today the ptm stated the alarm date was (b)(6) 2018.This morning ((b)(6) 2018) the patient complained of feeling sweaty and had flu like symptoms.Her pump was alarming a dual tone without the ptm showing a code of 8286 (empty reservoir).The hcp had not seen the pump logs to confirm when the actual empty reservoir alarm occurred.They refilled the pump and the expected residual volume (erv) was 0 milliliters and the actual residual volume (arv) was 1.5 milliliters.The arv was consistent with previous refills.It was discussed to check the ptm tech report and pump pa logs to confirm the patient¿s actual use of the ptm (pa blousing).No further complications were reported/anticipated or expected.

• 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: 7526831
• MDR Text Key: 108735309
• Report Number: 3004209178-2018-11305
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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: Other
• Type of Report: Initial
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2018
• Date Device Manufactured: 10/27/2015
• 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 Age: 43 YR