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

Model Number 8637-40

Device Problems Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017)

Patient Problems Arrhythmia (1721); Fall (1848); Headache (1880); Hypersensitivity/Allergic reaction (1907); Tinnitus (2103); Dizziness (2194); Ambulation Difficulties (2544); Cognitive Changes (2551); Insufficient Information (4580)

Event Date 05/14/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient who was receiving morphine of an unknown concentration at an unknown dose rate via an implantable pump for spinal pain.It was reported that the pump was implanted on (b)(6) 2021 and since then, when he woke up, the patient started having symptoms of severe headache, heart palpitations, ear ringing and light-headedness.It was noted that the patient was allergic to morphine but that is what was put in his pump.Hydromorphone was what was supposed to be in the pump.The patient had made an appointment with their physician who had told him that he would address the symptoms in two weeks.The patient was questioning if the a company representative could turn off the pump.Additional information was received via a consumer on (b)(6) 2021.It was noted that since implant the patient had a splitting headache that was due to the pump having the wrong medication in it.The patient does not react well to morphine.It was further noted that the pump they were shown was much smaller than what was implanted.The patient had visited their physician on (b)(6) 2021 was told their side effects were normal after implant.The patient had really bad pressure in her head and it felt like their "eyes and ears are going pop out".They also had a roaring headache and ringing in their ears.The patient was unstable and had fallen a few times because she was dizzy and unstable, lightheaded, and was having trouble with her balance.It was further described that their head was so messed up they can't keep track of anything.The patient had also requested the dimensions of the pump.The patient was redirected to their healthcare provider to address the issue.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11989305
• MDR Text Key: 255973418
• Report Number: 3004209178-2021-09277
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2021
• Date Device Manufactured: 02/05/2021
• 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 Age: 61 YR