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

Model Number 97714

Device Problems High impedance (1291); Connection Problem (2900)

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

Event Date 05/29/2014

Event Type  malfunction  

Event Description

It was reported that during a replacement procedure for normal battery depletion, impedance testing with a snaplid showed electrode 3 with high impedances.Rest of the results were within normal limits.When the lead was connected to the new device, the bottom port felt difficult to advance into.The top lead had been placed first.The lead had been taken out and wiped down several times.High impedances continued even when tested at 3v.The leads were swapped (bottom lead to top port/vice versa) and high impedance was seen on both leads.When both leads were taken out and placed on the snaplid again, electrode 10 was showing high impedance.The physician planned to switch out the stimulator.It was further noted that the bottom lead went in much easier in the second stimulator that was opened and placed.It was clarified that there were normal readings prior to attaching to the initial stimulator but not when attached.

Manufacturer Narrative

Concomitant products: product id 3778-60, serial # (b)(4), implanted: (b)(6) 2008, product type lead; product id 3778-60, serial # (b)(4), implanted: (b)(6) 2008, product type lead.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Manufacturer Narrative

Final device analysis of the stimulator revealed no anomalies.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 3882041
• MDR Text Key: 4510941
• Report Number: 3004209178-2014-11777
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2014
• 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: 00032 YR