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

Model Number 97714

Device Problems Intermittent Continuity (1121); Energy Output To Patient Tissue Incorrect (1209); Failure to Interrogate (1332); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Event Description

The last few/couple days the patient¿s patient programmer (pp) has not been consistently connecting with his implantable neurostimulator (ins).It started with the pp not communicating with the ins every once in a while but now the pp does not communicate more often than it does communicate.At the time of the report the pp was not connecting with the ins at all.The patient changed the batteries in the pp but that did not resolve the issue.The patient only uses the pp with the antenna attached.During the report the patient tried communicating with the ins without the antenna attached but got the poor communication screen.The pp would not do telemetry with or without the antenna.The pp sometimes erratically works.Appears to have occurred through product use.No patient harm reported.It was confirmed that the ins was charged.Sometimes the device turns on when the patient does not expect it to.The patient thought he had it turned off the other day ((b)(6) 2014), when driving normal like (he might have moved) and it just came on full blast; he did not have the pp with.The patient received a replacement pp but still could not connect when the antenna was used.The patient was not able to make adjustments with the antenna attached.The antenna was damaged and a new one was requested.Upon ret urn of the recharger, analysis found the face plate scratched.C200.The antenna was not returned.C500.The patient confirmed on (b)(6) 2014 that he does not have concerns with his device or therapy at this time.If additional information is received, a follow up will be sent.

Manufacturer Narrative

Concomitant products: product id 37092, serial# unknown, product type accessory; 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.(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: 4213931
• MDR Text Key: 4995057
• Report Number: 3004209178-2014-20661
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/08/2014

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: 12/14/2014
• 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: 10/08/2014
• Initial Date FDA Received: 10/30/2014
• Date Device Manufactured: 01/23/2014
• 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: 00058 YR