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

Model Number 97714

Device Problems High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574)

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

Event Date 03/10/2014

Event Type  Injury  

Event Description

(b)(4).

Event Description

It was later reported that the case was scheduled for june 4th.

Event Description

The patient was getting jolted when he stands up that lasts 5 seconds and happens every 5-10 minutes.The ins was turned off and the patient will be seen on (b)(6) 2014 for troubleshooting (impedance and palpation).The shocking was in the medial part of the lower back and started on (b)(6).X-rays were taken on (b)(6) by the patient¿s implanting health care provider (hcp) which looked fine.There was no trauma or falls but the patient did have an mri around (b)(6) timeframe.The patient does not lift anything heavy.The patient is a cashier and very compliant with the weight limit restrictions.The patient felt that the ins moved from the lateral position to a more medical position but his hcp stated that when he saw the patient on the (b)(6) this was not true.The ins was sutured in.The pain was back to original pain as the ins was currently off to mitigate the shocking sensations.The patient does have adaptive stim and the settings have not been changed.The patient is very compliant.The standing amp was around 9v or so.The company representative reported on (b)(6) 2014 that the stimulation was tested up and down on the lead to see if the shocking/jolting felt by the patient was isolated to one or both leads.No matter what was programmed, these symptoms continue to be present and happens on both leads.It was unlikely to be the ins but there was no way to officially rule it out with troubleshooting.Electrodes 6 and 7 were the only electrodes reading ¿high¿.Palpation was done along system from lead line to battery, no jolting or shocking was felt while doing this.Different parts of the lead was tested.Symptoms still happened on left lower and then right same.The shocking was felt at the incision site and 6-12 inches up the spine.¿did it 3 to 4 times to patient¿ was noted.The patient ¿had it happen 6 times¿ since 1:15pm.All within 4-6 inches below incision site.The patient was not programmed to 6 and 7.Impedances were all normal following implant.Lead 0-7 was not even being used for programming therapy.Just one lead, 8-10, were being used.X-rays were done and showed leads were fully seated and fine.Issues started to happen on (b)(6).The patient will be scheduled for full revision and they plan to return all the devices to the device manufacturer.Intra-op troubleshooting will also be done but may have to explant everything if they cannot find where the issue is.An mri was done on the (b)(6) but did not show a thing.No frays or breaks in wire were seen.(b)(6) was another jolting.When the implant is turned off, everything goes away.X-rays showed no anomalies, lead location fine and loops nice.No migration issue was seen.No date for the revision procedure yet.It was additionally reported that the doctor decided on revision of leads and ins (complete revision).The stimulation was turned off.It was clarified that the jolting occurs just below the lead incision site and travels up towards his neck 6-12 inches.The leads were at t8-9 location.The patient had the mri on (b)(6) because he had thrown his back out around (b)(6) then saw his doctor on (b)(6).The jolting started before the patient pulled his back out so did not think it was related.The patient does use adaptive stim but the jolting did not seem to occur with position changes.Palpation was negative for any stimulation changes.The patient did have a couple jolting events since being at the clinic.As of (b)(6) 2014 the case had not been scheduled yet.

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.(b)(4).

Manufacturer Narrative

Device analysis for ins (b)(4) revealed no anomaly found.Device analysis for lead (b)(4)revealed the proximal end connector was not completely seated in the ins connector port.

Event Description

It was confirmed that the patient recovered from the procedure.

Manufacturer Narrative

Event Description

The patient was scheduled for a complete revision on (b)(6) 2014.

Manufacturer Narrative

(b)(4).

Event Description

It was additionally reported that the doctor thought the patient may have aspirated some fluid during surgery.

Manufacturer Narrative

Concomitant medical products: product id 977a260, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2014, product type: lead.Product id 977a260, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2014, product type: lead.(b)(4).

Event Description

It was confirmed that the system was removed.No malfunctions were seen.A new system could not be implanted.The patient had soda in the am and started to get sick during removal.The system was removed and closed.The product was going to be returned to the device manufacturer.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; 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: 3751527
• MDR Text Key: 4508143
• Report Number: 3004209178-2014-07236
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2013
• 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: 00053 YR