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

Model Number 8637-20

Device Problem Electromagnetic Interference (1194)

Patient Problem Fall (1848)

Event Date 06/08/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from the healthcare provider (hcp) regarding a patient receiving morphine (25 mg/ml at 9 mg/day) via an implantable infusion pump.The indication for use was non-malignant pain and failed back surgery syndrome.It was reported that the patient had fell and was admitted to the hospital.A magnetic resonance imaging (mri) was performed at 09.59 and a motor stall was seen at the initial interrogation more than 2 hours since the imaging was done.The caller stated that she did not hear any audible pump alarm.The pump was re-interrogated for a new set of logs and a motor stall recovery was confirmed.No further complications have been reported as a result of this event.

• 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: 8691958
• MDR Text Key: 147753885
• Report Number: 3004209178-2019-11444
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 06/12/2019
• Date Device Manufactured: 02/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0591-2009
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR