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

Model Number 8637-40

Device Problems Migration or Expulsion of Device (1395); Human-Device Interface Problem (2949)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2020, product type: catheter.Product id: neu unknown.Product type: programmer, physician.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving (b)(6) (5mg at.5998 mg) via an implantable pump for spinal pain.It was reported that patient pump was suspected to be flipping in the pocket.The patient didn¿t have loss of therapy just difficult time to use ptm and refilling her pump.Today (b)(6) 2021 we revised the pump.Hcp inspected catheter and aspirated from cap chamber.Hcp was able to aspirate 2cc.There seemed to be no issues to catheter integrity.Also hcp anchored all four pump tie downs as he previously did for pump replacement back in 2020.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12866017
• MDR Text Key: 284371402
• Report Number: 3004209178-2021-17539
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2021
• Date Device Manufactured: 09/24/2020
• 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): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female