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

Model Number 8637-40

Device Problems Failure to Interrogate (1332); Unstable (1667)

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

Event Date 12/31/2017

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 healthcare professional via manufacturer representative.It was reported that the flipped pump was the cause of the failed communication.The cause of the pump flipping was a loose pocket.The poor communication caused the bolus lockouts.The patient's weight at the time of the event was unknown.No actions/interventions had been performed, however the patient may be referred to a surgeon for a pocket revision.The failed communication, pump flip and lockouts were not resolved.The patient was not able to re-establish communication with the pump following the unsuccessful communications.No further complications were reported.

Manufacturer Narrative

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

Event Description

Information was received via manufacturer representative (rep) from a patient who was receiving fentanyl (500 mcg/ml, 75 mcg/day) and bupivacaine (10 mg/ml, 1.5 mg/day) via intrathecal drug delivery pump for spinal pain.It was reported that a bolus was unexpectedly declined.The patient had complained of intermittent episodes where she was getting locked out of patient activated (pa) boluses when she thought she should not be locked out.The lock out parameters were 3 hours, dose restriction interval 2/4 hours, maximum 4.The pump pa logs showed only 88 codes, no 89 codes.The rep had not pulled the personal therapy manager (ptm) technical report.The rep would get this report and review the reason for lockouts.The patient had been getting repeated unsuccessful communication with the ptm; her pump had been flipping intermittently over the course of the last year.The last time it flipped was (b)(6) 2018 and the healthcare professional manually flipped it back.The patient had no pocket revision done.The rep was wondering if the failed communication with the ptm could be related to the pump being flipped.There were no reported symptoms.No further complications were reported.

• 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: 7318013
• MDR Text Key: 101903923
• Report Number: 3004209178-2018-04541
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2018
• Date Device Manufactured: 11/01/2016
• 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: 84 YR