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

Model Number 97714

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Shaking/Tremors (2515)

Event Date 09/12/2014

Event Type  malfunction  

Event Description

The patient experienced an overstimulation sensation.The patient was currently in the er and was brought by ambulance.The patient reported excessive shaking and stimulation over entire body, and called 911.The sensation first started in her arms and then went over entire body.The shaking started about a half hour ago.The symptoms were a sudden change.The patient did not bring the patient programmer (pp) or recharger to the hospital.A family member was in route to get both devices.The health care provider (hcp) wanted to know if there was a way of turning the device off remotely.The patient was in a lot of pain.The er hcp had a remote/pp and was able to turn the implantable neurostimulator (ins) off.The stimulation issue resolved.Additional information has been requested to find out if troubleshooting or intervention was required and the outcome of the event.If additional information is received, a follow up will be sent.

Manufacturer Narrative

Product id 97740, serial# (b)(4); product type programmer, patient product id 97754, serial# (b)(4); product type recharger product id 97792, lot# n413206, implanted: 2014 (b)(6); product type accessory product id 977a275, serial# (b)(4), implanted: 2014 (b)(6); product type lead product id 977a275, serial# (b)(4), implanted: 2014 (b)(6); product type lead.(b)(4).

Manufacturer Narrative

(b)(4).

• 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: 4131806
• MDR Text Key: 4941950
• Report Number: 3004209178-2014-18049
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2014
• Date Device Manufactured: 04/15/2014
• 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 Age: 00057 YR