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

Model Number 97702

Device Problems Device Displays Incorrect Message (2591); Loss of Data (2903)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2015

Event Type  malfunction  

Event Description

It was reported that the patient had their stimulator replaced to a 97702 due to normal depletion.The company representative transferred the 5 groups, each with 3 programs, to the new device during the pre-operative/intra-operative time frame.When she went to go check on the patient in recovery none of the groups were saved.The programmer screen showed 8840/antenna/ins.A clinician programmer was used and confirmed that no groups were saved and it directed the representative to start over from the lead configuration screen.The company representative was able to transfer the groups the second time around and they did save properly.The stimulator was turned on and off several times and re-checked with the programmers.

Manufacturer Narrative

Concomitant products: product id: 37712, serial# (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2015, product type: implantable neurostimulator.Product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 39565-30, serial# (b)(4), implanted: (b)(6) 2008, product type: lead.Product id: 3708160, serial# (b)(4), implanted: (b)(6) 2008, product type: extension.Product id: 3708160, serial# (b)(4), implanted: (b)(6) 2008, product type: extension.(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: 4484956
• MDR Text Key: 5565335
• Report Number: 3004209178-2015-01775
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2016
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2015
• Date Device Manufactured: 10/28/2014
• 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: 00062 YR