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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); High impedance (1291)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 11/03/2014

Event Type  malfunction  

Event Description

It was further reported that the plan was to see the patient at their post operative appointment (date unknown).If there was not better coverage, they would discuss a revision to check the extensions and/or the lead.

Event Description

It was reported that during a replacement procedure for normal battery depletion, high impedances were seen.Contacts 4-7 were high at greater than 20,000 ohms (also stated greater than 40,000 ohms) at 1.5v.When the test was re-run at 3.0v, they ranged from 16,000-17,000 ohms.The lead tails were connected to a pocket adaptor.The 1x8 lead was inserted into the top port of the new stimulator.The company representative was confident the configuration was correct.Re-wiping and drying the connections did not change the results.Of note, impedance values for 0-3 were in the range of 1,000 ohms.Another pocket adaptor was then tried.At 3.0v, they came down into the 8,000-9,000 ohm range.It was also stated that they were down into the 2,000 ¿ 3,000 ohm range.In recovery, they fluctuated back up into the 16,000 to greater than 40,000 ohm range.The patient also only had coverage on the right side.They were unable to feel stimulation on the left side (on 0-3), even after going up to 10v.The group impedances were run in recovery after the electrode configuration was changed and resulted in 552 ohms.Since the group impedance was fine, they planned to monitor the patient and see if impedances come down.The patient¿s status was alive with no injury.It was unknown at the time of the report if the impedance issue resolved.Additional follow up was done to obtain this information, as well as outcome.If received, a follow up report will be sent.

Manufacturer Narrative

Product id: 74002, lot# n444244, product type: adapter.The adaptor was returned for analysis.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Manufacturer Narrative

Concomitant medical products: product id 74002, lot# n501074, implanted: (b)(6) 2014, product type: adapter; product id 748940, serial# (b)(4), implanted: (b)(6) 2003, product type: extension; product id 748940, serial# (b)(4), implanted: (b)(6) 2003, product type: extension; product id 74002, lot# n501074, implanted: (b)(6) 2014, product type: adapter; product id 3998, lot# lb3690, implanted: (b)(6) 2003, product type: lead; product id 97740, serial# (b)(4), product type: programmer, patient; product id 97754, serial# (b)(4), product type: recharger.(b)(4).

Manufacturer Narrative

Analysis of the 74002 adaptor (lot # n444244) found no anomalies with the device.

Event Description

Additional information received reported the patient had been doing well and there had been no complaints from them.

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: 4246364
• MDR Text Key: 5105201
• Report Number: 3004209178-2014-21440
• 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,Followup,Followup
• Report Date: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2014
• 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: 00070 YR