MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTED DEVICE FOR PAIN RELIEF; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Arrhythmia (1721); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Failure of Implant (1924); Shaking/Tremors (2515)

Event Date 01/01/2015

Event Type  Injury  

Event Description

Reporter calling, stating "about seven years ago" it was discovered he was having heart palpitations, with "sporadic" blood pressure described as alternating between high and low at various and random times.He was admitted to the hospital for these reasons, and believes the device was the cause of his troubles.Reporter states he has had continuing health problems due to the medtronic device originally implanted for pain relief.He states that the leads on the device broke and were replaced in 2017, however his health problems continued.He states the device was explanted "a couple months ago" earlier this year (2022).He states that when the leads were being removed, that his legs were shaking.He continues to experience "tingling" in the area of his spinal cord/lower back "from the waist down." he continues to suffer from heart palpitations and states that this device has caused permanent damage to his body.He has contacted medtronic regarding his problems, and will be pursuing legal action because "they really profanity.".

• Brand Name: IMPLANTED DEVICE FOR PAIN RELIEF
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 15104876
• MDR Text Key: 296708070
• Report Number: MW5111120
• Device Sequence Number: 1
• Product Code: LGW
• 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: 07/25/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 136 KG
• Patient Race: White