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

Model Number 8637-40

Device Problems Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 04/26/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2018, information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient receiving an unknown drug (unknown dose and concentration) via an implantable pump for non-malignant pain.On (b)(6) 2018, during a normal refill procedure, the 8840 (physician programmer) indicated there should be 5 ml (expected reservoir volume (erv)) of drug in the pump.The hcp aspirated the pump and the volume was 0 (actual reservoir volume (arv).The hcp indicated that they had been "getting more volume out of the reservoir before on a refill".No more specific information was provided regarding the previous volume discrepancies.The patient was "experiencing apparently some withdrawal symptoms".The ptm was "apparently" using a future date for an alarm date.The hcp refilled the pump as usual.The hcp scheduled the patient to return to the office in about a week to check the reservoir volume.There were no known environmental, external, or patient factors that may have led or contributed to the event.There were no known diagnostics or troubleshooting performed.The resolution of the event was unknown.The patient's status was alive - no injury.

Manufacturer Narrative

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

Event Description

On (b)(6) 2018, additional information was received from a manufacturer representative (rep) which was confirmed with the healthcare professional (hcp).It reported the patient was receiving morphine (64 mg/ml, 65 mg/day), bupivacaine (12 mg/ml, 12.197 mg/day), sufentanil (800 mcg/ml, 813.10 mcg/day), gabapentin (30 mg/ml, 30.491 mg/day) and fentanyl (450 mcg/ml, 457.37 mcg/day).The rep reported the actions taken to resolve the event was "pump was refilled as normal".The exact volumes and dates of the previous volume discrepancies was unknown.The rep was "not sure" of the symptoms the patient was experiencing.The rep was "not sure" when the symptoms started.The rep was "not sure" about what future date the ptm was using.

• 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: 7473473
• MDR Text Key: 106960377
• Report Number: 3004209178-2018-09640
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2018
• Date Device Manufactured: 07/13/2016
• 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: 59 YR