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

Model Number 8637-20

Device Problems Electromagnetic Interference (1194); Protective Measures Problem (3015)

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

Event Date 10/21/2018

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 professional regarding a patient who was receiving 10mg/ml dilaudid at 1.1mg/day and 5mg/ml bupivacaine at 0.5502mg/day via an implantable infusion pump for non-malignant pain.It was reported that the pump was alarming.When interrogate with the tablet (a810 physician programmer app) the pump read "code 07: critical alarm-pump defaulted to minimum rate." the hcp used a 8840 physician programmer to confirm the pump was in safe state.The pump was implanted on (b)(6) 2018.No symptoms were reported.No further complications were anticipated/reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer's representative (rep).It was reported that the pump was reprogrammed out of safe state and updated sometime the previous week (relative to 2018-(b)(6)).The pump went into another safe state the night of 2018-(b)(6) while the patient was in bed, which is where they were when the first safe state occurred.It was reported that the patient had an electric bed.It was reported that the bed was the same bed utilized with the previous pump which had no issues.It was reported that the bed had magnets in it.It was reported that the patient's healthcare professional planned to remove the pump.No further complications were anticipated/reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp).It was reported that the pump was being replaced on (b)(6) 2018 and will be returned for analysis.No further complications were anticipated/reported.

Manufacturer Narrative

The device was returned and analysis found an unexplained safe state event.If information is provided in the future, a supplemental report will be issued.

• 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: 8015855
• MDR Text Key: 125705571
• Report Number: 3004209178-2018-24139
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 56 YR