MAUDE Adverse Event Report: ABBOTT MEDICAL PROCLAIM SPINAL-CORD STIMULATOR; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 3660

Patient Problems Pain (1994); Distress (2329)

Event Date 07/01/2023

Event Type  Injury  

Event Description

Patient called to report product issues with her abbott device.Patient stated she received a call from abbott letting her know there is a class 1 recall involving her proclaim device.Patient stated the class 1 recall is due to the device being unable to go into mri setting.Patient stated she was denied an mri in (b)(6) 2023 because of her proclaim device not going into mri mode and she's been informed she cannot receive any mri's while this device is implanted.Patient stated she has crps (complex regional pain syndrome) which is very painful, and her device helps her a great deal, but she needs an mri which she now cannot get due to this recall issue.She also stated that she's tried calling abbott a bunch of times, but she keeps getting hung up on.Patient stated this recall issue is causing her a lot of physical and mental distress and that it is a complete "nightmare".

• Brand Name: PROCLAIM SPINAL-CORD STIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 18364647
• MDR Text Key: 331078536
• Report Number: MW5149395
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 3660
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Female