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

Model Number 97713

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problems Device Overstimulation of Tissue (1991); Electric Shock (2554)

Event Type  malfunction  

Event Description

It was reported that the patient felt a shocking/jolting sensation when the device was turned up to 9.5 the day of the report.The patient stated this was too much stimulation.The patient was having difficulties with proper communication between the stimulator and the patient programmer.The device had just been implanted.The patient was assisted with successful operation of the programmer.It was further reported that the cause of the event was turning on the stimulator without changing the voltage.There were no abnormal impedances or interventions noted.

Manufacturer Narrative

Concomitant medical products: product id: 97791, lot# n435580, implanted: (b)(6) 2014, product type: accessory.Product id: 3777-45, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 97754, serial# (b)(4), product type: recharger.Product id: 3777-45, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 97740, serial# (b)(4), product type: programmer, patient.(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: 3827484
• MDR Text Key: 4390726
• Report Number: 3004209178-2014-09485
• 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: 05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2014
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2014
• Date Device Manufactured: 10/31/2013
• 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: 00079 YR