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

Model Number 97714

Device Problems Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problems Muscular Rigidity (1968); Therapeutic Effects, Unexpected (2099); Ambulation Difficulties (2544)

Event Date 03/23/2014

Event Type  malfunction  

Event Description

The patient experienced no stimulation sensation.The patient stated ¿my battery is on but i¿m not getting no stimulation for my left leg¿.This started ¿yesterday¿.The patient went to the er yesterday and ¿my battery was on but no stim¿.The patient¿s lower back locked up on her and her left leg gave out.There have been no falls, traumas or accidents.The only thing the patient did yesterday was help put a bed frame together.The patient synched her patient programmer (pp) to ins to get settings and it was verified that the ins was off.There was only 1 program and it was at 9.0.The patient¿s normal setting was 3.25 and 2 something.When the patient went to lower her settings, she saw the icons to replace the pp batteries, she then replaced the batteries.Now the pp screen showed the ins was on, group a active, program 1 (left leg) was at 5.0v and program 2 (right leg) was at 2.60v.The patient stated she¿s ¿not getting anything¿.The patient then increased to 5.6 and 3.0 and did not feel anything.Then increased to 6.0 and still did not feel anything.The patient has an appointment with her doctor tomorrow.The patient¿s health care provider (hcp) reported on (b)(6) 2014 that the patient had a ct scan of the lumbar spine on (b)(6) 2014.The stimulator wires enter the spinal canal from the posterior bilaterally at upper level of t12.The wires were located in the position consistent with an epidural location bilaterally.The device was reprogrammed sometime in the past week.The patient was in for an appointment on (b)(6) 2014 and the stimulation was restored.It was noted that the patient did go to the er for evaluation.The patient outcome was noted as no injury.

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.Product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 97754, serial# (b)(4), product type: recharger.(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: 3748985
• MDR Text Key: 21312784
• Report Number: 3004209178-2014-07188
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2014

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: 03/24/2014
• Initial Date FDA Received: 04/14/2014
• Date Device Manufactured: 07/20/2013
• 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: 00042 YR