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

Device Problems Product Quality Problem (1506); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 07/18/2019

Event Type  Injury  

Event Description

Abbott labs nerve stimulator double booster increased leg pain to point of emergency room visits.Just had it removed (b)(6) 2021 should be prohibited for sale.Company admits design flaw.Fda safety report id# (b)(4).

• Brand Name: DOUBLE BOOSTER NERVE STIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 11825021
• MDR Text Key: 250887342
• Report Number: MW5101355
• Device Sequence Number: 1
• Product Code: GZB
• 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: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 116