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

Model Number 97713

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Therapeutic Effects, Unexpected (2099); Electric Shock (2554)

Event Date 06/11/2014

Event Type  malfunction  

Event Description

The patient experienced a shocking or jolting sensation.The patient was reprogrammed on (b)(6) 2014.The patient was getting shocked in their legs.The ins was now off and the shocking has stopped.The therapy was not working as expected.The patient wants the programs back to what they were prior reprogramming.The patient would like to meet with a company representative to have the device checked and/or programmed.The company representative met with the patient three days later.Whether using the new programs or the old ones, the patient goes from not feeling any stimulation to ¿shocking¿ stimulation, and back without any changes being made to amplitude.The stimulation was in the proper areas but the wild variance in perception of the stimulation was unusual.The patient¿s physician was concerned that the lead may have migrated so a ct scan was ordered but the results were not yet known.All impedances were normal, between 700-1000 at 0.7v.The patient was instructed to leave the device off until he was able to get the ct scan and troubleshooting could be done further.A week later, it was confirmed via ct scan that the lead migrated caudally to the top of t10, it was implanted with the top of the lead at t7.Upon review of the image a follow up appointment was attempted to be made with the patient.The patient was not yet aware that the lead migrated.The patient and physician need to discuss the appropriate course of action.Additional information has been requested.

Manufacturer Narrative

Concomitant products: product id 97754, serial # (b)(4), product type recharger; product id 97740, serial # (b)(4), product type programmer, patient; product id 39565-65, serial # (b)(4), implanted: (b)(6) 2014, product type lead; product id 39565-65, serial # (b)(4), implanted: (b)(6) 2014, product type lead.(b)(4).

• 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: 3914100
• MDR Text Key: 21808627
• Report Number: 3004209178-2014-12536
• 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
• Report Date: 06/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2014
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2014
• Date Device Manufactured: 09/20/2013
• 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 Age: 00059 YR