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

Model Number 8637-20

Device Problems Electromagnetic Interference (1194); Mechanical Jam (2983)

Patient Problem Pain (1994)

Event Date 07/18/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a manufacturer representative regarding a patient receiving an unknown drug with an unknown dose and concentration via an implantable pump for non-malignant pain.It was reported personal therapy manager (ptm) showed code 8476 meaning a motor stall occurred.It was noted the patient had a magnetic resonance imaging (mri).The patient reported to the manufacturer representative (rep) that they had a thoracic mri today ((b)(6) 2017), and during the procedure they experienced pain in their legs so they stopped the procedure for a period of time.When the mri was stopped, the patient receiving a patient administered (pa) bolus and confirmed 8476 code via their ptm/8835.Code meaning and other relevant information was reviewed.Event date was noted as (b)(6) 2017.No further complications were reported/anticipated.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from healthcare professional on 2017-jul-27 reported the patient's weight was about (b)(6).It was noted that the motor stall and pain was resolved as the personal therapy manager (ptm) was used.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from a manufacturer representative (rep) on 2017-jul-26 reported the patient called the rep.It was noted that at the time the patient reported this to the rep, they had just gotten out of the "magnet".It was noted that the motor stall recovered shortly after.It was a normal motor stall due to magnetic resonance imaging (mri).It was noted that the motor stall resolved, but the rep did not known if or when the pain resolved.The patient's weight at time of event was unknown.No further complications were reported/anticipated.

• 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: 6745138
• MDR Text Key: 81156934
• Report Number: 3004209178-2017-15631
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2017

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: 01/28/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/18/2017
• Initial Date FDA Received: 07/26/2017
• Supplement Dates Manufacturer Received: 07/26/2017; 07/27/2017
• Supplement Dates FDA Received: 07/27/2017; 07/28/2017
• Date Device Manufactured: 07/29/2016
• 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#Z-0591-2009
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 57