MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO PRIMEADVANCED; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37702

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problems Emotional Changes (1831); Pain (1994); Swelling (2091); Distress (2329); Complaint, Ill-Defined (2331); Injury (2348); Deformity/ Disfigurement (2360); Disability (2371)

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 355531, lot# n332139, implanted: (b)(6) 2012, product type: screening device.Product id: 355531, lot# n332243, implanted: (b)(6) 2012, product type: screening device.Product id: 37744, serial# (b)(4), product type: programmer, patient.Product id: 3778-60, serial# (b)(4), implanted: (b)(6) 2012, product type: lead.Product id: 3778-60, serial# (b)(4), implanted: (b)(6) 2012, product type: lead.Product id: 3778-60, serial# (b)(4), implanted: (b)(6) 2012, product type: lead.Product id: 3778-60, serial# (b)(4), implanted: (b)(6) 2012, product type: lead.(b)(4).

Event Description

Relevant medical history included peripheral neuropathy and spinal pain.The consumer's legal representative reported the patient received injuries as a result of negligence with regard to the neurostimulator product.On (b)(6) 2016 the manufacturer was made aware of additional information provided by the consumer's legal representative reported that prior to (b)(6) 2015 a neurostimulator was implanted into the patient's spinal cord.Subsequent to the surgeries, the patient began to feel pain, swelling, and other symptoms associated with defective or broken stimulators.The patient discovered that the lead wires to the neurostimulator were broken and that it would require at least two surgeries to remove the neurostimulator and wires.It was reported that as a direct result of the negligence from the manufacturer the patient suffered great bodily injury, resulting in pain and suffering, disability, disfigurement, mental anguish and loss of capacity for enjoyment of life, aggravation of a pre-existing condition, expense of hospitalization and medical and nursing care and treatment.The patient's losses were reported to be either permanent or continuing and would continue in the future.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PRIMEADVANCED
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5598524
• MDR Text Key: 43341620
• Report Number: 3004209178-2016-08051
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2013
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2016
• Date Device Manufactured: 01/20/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization