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

Model Number 8637-20

Device Problems Excess Flow or Over-Infusion (1311); Difficult to Interrogate (1331); Device Displays Incorrect Message (2591); Application Program Problem (2880); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

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

Event Date 07/01/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8590-1, lot# n522026, implanted: (b)(6) 2015, product type: accessory.Product id: 8781, serial# (b)(4), implanted: (b)(6) 2015, product type: catheter.Product id: 8835, serial# unknown, product type: programmer, patient.(b)(4).

Event Description

The patient was getting locked out of boluses by the ptm (personal therapy manager) and he should have been able to get one.The patient was seeing 4 hours which was his lockout interval.He noticed it about a week after getting the ptm.He did already use an antenna with his ptm.The patient had no symptoms related to the event.The patient also reported that on (b)(6) 2015 he gave himself a bolus as 12:17, he got his next one at 4:22, and then attempted a bolus later to see how much time was remaining and instead it gave him a bolus and it shouldn't have.The patient planned to follow-up with his hcp (healthcare professional) in two weeks.On (b)(6) 2015, the patient reported that in (b)(6) 2015 he stated seeing a 0617 code on his ptm.On (b)(6) 2015 at 7:21am he requested a bolus and saw 0617; he tried again at 7:23am and the bolus was delivered.The patient stated that he was "okay now that he knows it was delivered".The interventions and outcome were not reported.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Event Description

Additional information received reported that the healthcare provider did not have any pump logs from that date and the patient had not been seen for the issue.

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4932090
• MDR Text Key: 24567687
• Report Number: 3004209178-2015-13867
• 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,health professional
• Reporter Occupation: Other
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2015
• Date Device Manufactured: 02/13/2015
• 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: 00048 YR