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

Model Number 8637-20

Device Problem Pumping Stopped (1503)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

The pump was reported to have been implanted in 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare provider (hcp) via a manufacturer's representative regarding a patient who was receiving an unknown drug via an implantable pump for an unknown indication for use.It was reported a 15 minute motor stall occurred on (b)(6) 2021.It was indicated the patient had their bag on their lap with an (b)(6) in it.There was no repeat of the motor stall.There was no reported patient impact.Further complications were not reported.Additional information was received.It was indicated the patient had an (b)(6).At the time of occurrence, they did not have any [(b)(6)] accessories like a magsafe in their bag and there were no other magnetic devices.It was reported the patient was in their living room of their home at the time of the critical alarm.They had their purse/bag on their lap, which contained their (b)(4).They never put their phone on their pump, but because the bag was on their lap, the phone was probably close to the pump.There had been no repeat of a motor stall.It was indicated the patient lived at home, so provoking the alarm would not be feasible.The nurse practitioner instructed the patient not to keep the phone on or near the pump.The pump logs were checked.No further actions beside instructing the patient as previously described were taken.The issue was considered resolved.The patient status was alive - no injury.A session report from (b)(6) 2021 at 11:28 was provided.The pump was delivering compounded baclofen (2,000.0 mcg/ml at 464.7 mcg/day).The motor stall occurred on (b)(6) 2021 at 17:10 and recovered at 17:22.Additional information was received.The patient lived in their own home and was wheelchair-bound due to a spinal cord injury.The patient was at home at the time of the event, and there were no "special features" around them.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11386420
• MDR Text Key: 233804611
• Report Number: 3004209178-2021-03320
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2021
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2021
• Date Device Manufactured: 04/08/2020
• 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: 27 YR