MAUDE Adverse Event Report: ABBOTT MEDICAL PROCLAIM IMPLANTABLE GENERATOR, BATTERY & WIRE; DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF

Model Number MN10450-50A

Device Problem Energy Output Problem (1431)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2020

Event Type  malfunction  

Event Description

The stimulator was giving resistance to the energy.Proclaim implantable generator (model: 10450-50a, lot: ab2346).Proclaim implantable battery (model: 3664, serial: (b)(4)).Slimtip implantable wire (model: mn10450-50a, lot: ab2421).

• Brand Name: PROCLAIM IMPLANTABLE GENERATOR, BATTERY & WIRE
• Type of Device: DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston road; plano TX 75024
• MDR Report Key: 9818715
• MDR Text Key: 182980191
• Report Number: 9818715
• Device Sequence Number: 1
• Product Code: PMP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MN10450-50A
• Device Catalogue Number: MN10450-50A
• Device Lot Number: AB2346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2020
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14235 DA