MAUDE Adverse Event Report: ABBOTT MEDICAL PROCLAIM NEUROSTIMULATOR / PULSE GENERATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	PROCLAIM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Reporter called to report an issue with his implanted proclaim neurostimulator.He first received his implant for pain relief on (b)(6) 2018.It was revised on (b)(6) 2020 and was reassured that the revision allowed it to be magnetic resonance imaging (mri) compatible.He recently received a letter from abbott about a recall on his device although it is still considered compatible with the mri procedure.Reporter now needs a lower lumbar mri but is not able to get one due to his recalled device.He has attempted to get an mri at five different facilities but all of them have turned him down due to the notice of his recalled neurostimulator.His regular facility of care has notified him that he can no longer get treatment from them due to the recalled device.Reporter states that he is in constant pain, and has been told that in order to restore the treatment that he needs, he would have to have another surgical procedure for an updated device that is mri compatible.

• Brand Name: PROCLAIM NEUROSTIMULATOR / PULSE GENERATOR
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 18102337
• Report Number: MW5147979
• Device Sequence Number: 12483784
• Product Code: LGW
• UDI-Device Identifier: 05415067046970
• UDI-Public: 5415067046970
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 11/08/2023

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?: Yes
• Device Model Number: PROCLAIM
• Device Catalogue Number: 3660
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Sex: Male