MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637

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

Patient Problems Wound Dehiscence (1154); Fatigue (1849); Headache (1880); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Anxiety (2328); Malaise (2359); Post Operative Wound Infection (2446); Sleep Dysfunction (2517); Fluid Discharge (2686); Alteration in Body Temperature (4568)

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 foreign consumer with sudeck¿s disease, complex regional pain syndrome (crps), algodystrophie receiving intrathecal ziconotide for pain therapy via an implantable pump.The dose and concentration were unknown.It was reported the patient was admitted in their pain clinic again due to an infection on the wound from the pain pump surgery.The wound was still leaking, and the patient was feeling ill.The patient felt sick.The patient felt cold and then hot.The patient experienced a massive headache and slept the whole afternoon.The patient experienced fear and worry.The plan was to administer strong antibiotics through the veins and change the wound dressing daily.It was further reported that the patient would undergo surgery to ¿clean the wound etc.¿ at 2pm on (b)(6) 2021.The hcp was able to see the pump through the wound, and that was the sign that surgery was urgently required.The patient still felt miserable, and something serious was going on in their body.The patient was ¿headed to the operating room for the second time (third time if you count the placement of the catheter).¿ it also was noted that the patient was awaiting covid-19 test results.

Manufacturer Narrative

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

Event Description

Additional information was received.The patient experienced a bloody incision after implant.The patient was still in the hospital, and the healthcare provider (hcp) would take care.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11381989
• MDR Text Key: 241039437
• Report Number: 2182207-2021-00317
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8637
• Device Catalogue Number: 8637
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 03/01/2021
• Supplement Dates FDA Received: 03/05/2021
• 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 Outcome(s): Hospitalization; Required Intervention