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

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Unspecified Infection (1930); Muscle Weakness (1967); Paralysis (1997); Viral Infection (2248); Numbness (2415)

Event Date 10/25/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare professional (hcp) and a consumer via a company representative regarding a patient receiving hydromorphone (1.0 mg/ml at 0.1600 mg/day) via an implanted pump.The patient¿s ptm (personal therapy manager) programming was a 0.0999 mg bolus, 2 activations, and 6-hour lockout.The indication for pump use was non-malignant pain.On (b)(6) 2018 the er (emergency room) physician reported that the patient was in (b)(6) when she started feeling weakness which worsened and now she was in the er paralyzed from the belly button down.The hcp wanted to have the pump interrogated to confirm there were no issues with the pump.The pump managing physician¿s office had already been contacted and was aware of the situation.The pump was not audibly alarming.Additional information was received the same day ((b)(4) 2018) from the patient and the er physician via a company representative who reported that the issue began on (b)(6) 2018.Per the er physician, the patient¿s legs didn¿t feel right; she had weakness and a lack of feeling.The pump was interrogated, and no alarm was present during the interrogation.The last adjustment was on (b)(6) 2018.At the time of pump interrogation, the patient appeared normal with no signs of overdose or withdrawal.The environmental, external, or patient factor that may have led or contributed to the issue was noted to be that the patient experienced the issue while in (b)(6) during a wedding.No actions/interventions were taken to resolve the issue.The issue was not resolved at the time of the report.The patient status was reported as ¿alive ¿ with injury¿ with the details of the injury provided as ¿patient developed lack of feeling in both legs, describes a weakness and fell¿.On (b)(6) 2018, mri compatibility guidelines were being requested as they were going to do a thoracic mri to rule out a device related infection.No further complications have been reported as a result of this event.

Manufacturer Narrative

Review of the additional information received has determined that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event no longer meets the reporting requirements stipulated in 21 cfr 803.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received on 06-dec-2018 from a healthcare professional (hcp) who accessed the patient¿s records and provided that an mri was performed, but it was done at another facility in (b)(6) (the reporter was unsure of the location) and they did not know the results; however, it was confirmed that the patient did not have a device-related infection, they were still using the pump, and no interventions were made with respect to the devices or therapy.The reporter also indicated that there was no update to the previously reported thought that the patient most likely had viral transverse myelitis.No additional information was provided or known by the hcp.No further complications were reported/anticipated.

Manufacturer Narrative

Product id 8781 lot# serial# (b)(4) implanted: explanted: product type catheter product id 8781 lot# serial# (b)(4) implanted: explanted: product type catheter information references the main component of the system.Other relevant device(s) are: product id: (b)(4) serial/lot# (b)(4) , ubd (b)(4) 2020, udi# (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received on (b)(4) 2018 from a healthcare professional who reported that the cause of the patient¿s symptoms had not been determined but were most likely due to viral transverse (b)(4).The patient¿s care was ongoing.The device system remained implanted.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: 8059860
• MDR Text Key: 126967611
• Report Number: 3004209178-2018-25199
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/12/2018
• Supplement Dates Manufacturer Received: 11/14/2018; 12/06/2018
• Supplement Dates FDA Received: 12/03/2018; 12/10/2018
• Date Device Manufactured: 06/05/2018
• 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 Outcome(s): Other
• Patient Age: 58 YR