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

Model Number 8637-20

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 12/11/2020

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 8782, serial/lot #:(b)(4), ubd: 26-jun-2022, udi#: (b)(4), implanted: (b)(6) 2020 product type catheter.Product id: 8780, serial/lot #:(b)(4), ubd: 15-oct-2022, udi#: (b)(4), implanted: (b)(6) 2020, explanted:(b)(6) 2020, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was receiving prialt via an implantable pump for spinal pain.On (b)(6) 2020, it was reported that the patient rolled over in bed and felt a sharp pain in their spine about 4 weeks post-implant on (b)(6)2020.  the patient's catheter had reportedly moved from the front of the spine to the back side of the spine.On the (b)(6) 2020, the catheter was replaced.The patient contacted the consumer on (b)(6) 2020  stated that they felt that the catheter had moved again because they were experiencing the same sharp, stabbing, poking in their back.The pain was reportedly positional when the patient was sitting or bending at the waist or turning.The consumer confirmed that the patient was experiencing pain relief from the pump.The patient has crps and the pump was implanted in the back.

Manufacturer Narrative

Continuation of d10: product id 8782 lot# serial# (b)(6) implanted: (b)(6)2020 product type catheter product id 8780 lot# serial# (b)(6) implanted: (b)(6)2020 explanted: (b)(6)2020 product type catheter medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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 was received from the rep on (b)(6)2021.It was reported that the cause of the symptoms was not determined.On (b)(6)2020 the patient visited the hcp.There was no change in catheter position.The patient was instructed to possibly follow up with psychologist regarding other issues contributing to pain.The symptoms had resolved on the (b)(6)2022 visit.

• 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
• MDR Report Key: 11096769
• MDR Text Key: 227882506
• Report Number: 3004209178-2020-22796
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2022
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR