MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 97714

Device Problems No Device Output (1435); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Electric Shock (2554)

Event Type  Injury  

Event Description

The patient experienced a shocking or jolting sensation.The patient has pain when she turns the implantable neurostimulator (ins) on.The patient was having problems and something was wrong.The patient cannot even turn the stimulation on right now.There was no problem with recharging.About two days ago the patient turned on the ins and when she turned on the stimulation, she got shocked in the upper left rib cage in one spot.When the stimulation was on, no matter what program, the patient get the shocking.There have been no falls or trauma, and was not picking up any heavy boxes while moving.The patient has moved and currently did not have a new physician.An appointment was scheduled on (b)(6) 2014 with a new pain clinic, a company representative will also be there.The stimulator normally works so well, the patient thought something had moved, maybe during her household move.Additional information has been requested to find out if any intervention or troubleshooting was required and to obtain the outcome of this event.If additional information is received, a follow up will be sent.

Manufacturer Narrative

Concomitant products: product id 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type lead; product id 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type lead; product id 97754, serial# (b)(4), product type recharger; product id 97740, serial# (b)(4), product type programmer, patient.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported the patient was still having concerns regarding their device.The patient's leads had moved and they were having a hard time finding a new healthcare professional (hcp) to fix it.

Event Description

Additional information received from the healthcare provider (hcp) reported that it was unknown if there was 50% or greater symptom reduction.The lead and the implantable neurostimulator (ins) were involved in the event.It was unknown what troubleshooting was done for the issue.The event cause was not determined, it was unknown if it was device related and it was unknown if all parts of the lead were explanted.The ins was explanted at a different clinical site; the patient moved and didn't return to the hcp clinic.The hcp had requested medical records from the patient.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported that the patient felt a "grabbing sensation" that caused them to straighten their back.These were not pleasant for the patient to experience.The manufacturer representative (rep) met with the patient the day of the report to try to reprogram the device to see if they could get away from that grabbing sensation when stimulation was turned up.They were unable to get stimulation coverage into the legs.During programming, the rep was able to get some stimulation into one knee but in order to feel stimulation, the amplitude needed to be increased and that was when the patient felt a grabbing sensation.The patient location at the time of the report was in a clinic.Ap view x-rays were taken and one lead appeared to be midline and the left lead appeared to "span out"laterally.It was asked if the lateral view x-ray had been taken which it was noted that it hadn't.The rep had tried to program up and down the lead with various combinations but they could not get around the "grabbing sensation." impedances were run and it was reviewed that the impedance measurements were normal; the impedances were all in the 800-1,000 ohm range.It was later noted that the healthcare provider (hcp) was going to revise the patient and place a paddle lead.Hopefully that would fix the problem.Information regarding the revision and patient outcome has been requested.If additional information is received, a follow-up report will be sent.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4255088
• MDR Text Key: 20783524
• Report Number: 3004209178-2014-21620
• Device Sequence Number: 1
• Product Code: GZB
• 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,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2015
• Date Device Manufactured: 07/15/2014
• 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): Required Intervention
• Patient Age: 00047 YR