MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
|
Back to Search Results |
|
Model Number 97714 |
Device Problems
High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Communication or Transmission Problem (2896)
|
Patient Problem
Electric Shock (2554)
|
Event Type
malfunction
|
Event Description
|
It was reported that the patient¿s cervical stimulator had high impedances.Impedances were greater than 20,000 ohms.The affected electrodes were programmed around successfully.The patient stated he had fallen several times.It was noted that the battery was painful to touch.The patient was very thin and the battery was visible on the flank.It was further reported that the patient experienced a shocking sensation when the stimulator was on.This started about a month prior.The patient again stated he¿d had many falls and had scrapes on his knees.The patients status was alive with no injury.
|
|
Manufacturer Narrative
|
Concomitant: product id 977a275, serial# (b)(4), implanted: 2014-(b)(6) product type lead.Product id 977a290, serial# (b)(4), implanted: 2014-(b)(6), product type lead.Product id 977a275, serial# (b)(4), implanted: 2014-(b)(6), product type lead.Product id 977a290, serial# (b)(4), implanted: 2014-(b)(4).Product type lead, product id 97714, serial# (b)(4), implanted: 2014-(b)(6), product type implantable neurostimulator.(b)(4).
|
|
Manufacturer Narrative
|
(b)(4).
|
|
Manufacturer Narrative
|
Concomitant medical products: product id 977a275, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id 977a290, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id 977a275, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id 977a290, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id 97714, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.(b)(4).
|
|
Event Description
|
It was further clarified that serial (b)(4) was implanted in his right flank.Serial (b)(4) was the cervical pain device.The patient was getting more stimulation in his left arm than in his right, where he wanted the majority of coverage.When the implant (cervical) was interrogated, there were high impedances.However, the company representative was able to program around this and obtained great coverage in this right arm, right shoulder and neck.The patient was happy with this coverage.The shocking sensation was described as positional; the patient noticed it more when he sat extremely upright or turned his neck from side to side.The stimulation was programmed to gain coverage but not have the uncomfortable stimulation the patient referred to as shocking.The patients physician/staff were informed of the updates.
|
|
Search Alerts/Recalls
|
|
|