MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Fall (1848)

Event Date 10/09/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Additional information was received from the patient. It was reported that the patient stated that the pump did not work. No further complications were reported.

Event Description

Information was received from a patient who was receiving an unknown drug at an unknown concentration at a dose of "7. 5," unknown frequency] via intrathecal drug delivery pump for an unknown indication for use. It was reported that the patient had begun her trial for her pain pump the day before this report and she would be on it for 3 days. The patient reported that the night before this report, her legs were doing good with the pump, but in the midsection she was "hurting so bad". The patient reported that because of this, she went to the hospital and was given a dilaudid shot. The patient also reported that she went home the same day and fell down. The patient reported that the reason for her call was because the emergency room doctor at the hospital turned her pump off and she needed help turning her pump back on. The patient later on in the call corrected herself, stating that she did not think he turned it off all the way. The following troubleshooting was reported: the patient said she was reading from some type of external device that was given to her by a manufacturer representative that led her to believe that the pump wasn't turned "all the way off. " it was reported that the patient service specialist (pss) asked the patient what her d rug information was (type, dose, and concentration). The patient said she did not know the type or concentration, but responded that "7. 5" was her dose. Pss asked if she knew the unit for her dose and the patient said she did not know. No further complications were reported.  .

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6948873
• MDR Text Key: 101656955
• Report Number: 3007566237-2017-04391
• Device Sequence Number: 1
• Product Code: LKK
• 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

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/16/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 8637
• Device Catalogue Number: 8637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial