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

Model Number 97714

Device Problems Break (1069); Unintended Collision (1429)

Patient Problem Pain (1994)

Event Date 03/14/2014

Event Type  malfunction  

Event Description

It was reported that while riding a horse, the patient had an accident in (b)(6) 2014 in which he fractured 3 of his vertebrae.The patient was unsure of the date but stated that it was around (b)(6) 2014.After the accident, the patient got up from the ground and rode two more horses before he was not able to get up from his knees.The patient noted that he felt too weak to move and had to go into the hospital that night.An mri was done on (b)(6) 2014 when they did the spine lumbar without contrast.The patient stated that the report noted post-operative changes at the interior and posterior fusion with decompressive laminectomy present at the l4-l5.The spine stimulator catheter was present and the vertebrae alignment was normal.The transverse process fracture was present on the left at l3-l4 levels.No other fractures were identified and no evidence of channel or form of stenosis.The patient went and got the medical record because he did not believe that he had truly broken anything.The patient was given prescriptions for pain pills but never filled them.The patient stated that the pain was not very bad and that he was walking around the next morning and really did not think it was that bad of a deal.In a couple of weeks, the patient was not back riding the horses but was driving the truck feeding the cows and doing a lot of craw fishing.It was noted that the patient did not get back on the horse until the third week in (b)(6).About a month after the accident, the patient tried to ride a horse but after 10 minutes, he knew it was too soon.It was verified that the leads and implantable neurostimulator were working correctly.The patient stated that the machine was ¿totally awesome¿ when it was working correctly.The patient noted that prior to the fall the system was covering the pain well.After the fall, the patient had to have reprogramming done to cover the pain like it was before.The patient was reprogrammed in (b)(6) and then it was ¿stupid great.¿ the patient reported feeling excellent stimulation where he needed it.Impedances were all normal during that time.It was noted that the patient did not say that his fall in march had anything to do with the device.It was later reported that the health care professional told the patient there was no way the leads could not have been damaged with the fall and that they must be damaged due to the fall.

Manufacturer Narrative

Concomitant products: product id 977a260, serial# (b)(4), implanted: (b)(6) 2013, product type lead; product id 97740, serial# (b)(4), product type programmer, patient; product id 97754, serial# (b)(4), product type recharger; 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; 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; product id 977a260, serial# (b)(4), implanted: (b)(6) 2013, product type lead.(b)(4).

Event Description

The patient reported they broke as many as 13 bones throughout the back and was in the hospital and therapy for over a month.The indication for therapy was spinal pain.If additional information is received, a supplemental report will be sent.

Manufacturer Narrative

Disregard reg report 3004209178-2014-19688 - supplemental issued on 11-23-2015.The rationale as a malfunction and not a serious injury remains.

• 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: 4171283
• MDR Text Key: 5157666
• Report Number: 3004209178-2014-19688
• 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
• Report Date: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/02/2014
• Initial Date FDA Received: 10/14/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/23/2015; 11/24/2015
• Date Device Manufactured: 07/16/2013
• 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): Hospitalization
• Patient Age: 00047 YR