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); Insufficient Information (3190); Unintended Electrical Shock (4018)

Patient Problems Fall (1848); Pain (1994); Burning Sensation (2146); Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020-, information was received from a patient receiving fentanyl (unknown dose and concentration) and another unknown "numbing" medication via an implantable pump for spinal pain.The patient reported that they were supposed to have a pump revision on (b)(6) 2019, but the surgery was cancelled.The patient stated the revision was because the pump had moved down into their pelvic area and pushed into the "vaginal area" causing them pain.The pump moving had been determined in (b)(6) 2019 (specific date unknown).The patient stated a rep was made aware of the issue while in the hcps office, but did not know their first or last name.The patient then reported that their pump was alarming and needed to be fill.The patient was told by their healthcare professional (hcp) that the pump was doing a critical alarm and needed to be filled.The event date of this issue was (b)(6) 2020.The patient stated that the clinic couldn't get the mediation in until (b)(6) 2020 and they were going in then to get the pump filled.The patient then reported that they fell on (b)(6) 2019 and due to the fall, they were reporting the "pump is shocking her" and "medication is burning".The patient reported their hcp was aware.The symptoms occurred suddenly.Further clarification of the "pump is shocking her"; patient stated the pump was shocking her, "like an electrical shock, like a bad spark shooting up into the pelvic area and something makes her legs go out from under her which caused her fall".The patient stated that now, when the pump alarms, it was also shocking her.Further clarification of "medication is burning" stated the patient had fentanyl and another numbing mediation.The patient stated, "when the medication is spitting out of the pump, it is burning".Further clarification was attempted and "spitting out" meant the medication coming out of the catheter.The patient stated they went to the emergency room on (b)(6) 2019, and they did an x-ray and told her "they could only find part of it" meaning the pump/catheter, but the patient did not know what part they had found.The patient reported they met a rep at the hospital on (b)(6) 2019 to interrogate the pump.

• 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: 9629935
• MDR Text Key: 185496631
• Report Number: 3004209178-2020-01821
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2020
• Date Device Manufactured: 10/09/2014
• 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: 53 YR