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); High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Therapeutic Effects, Unexpected (2099); Electric Shock (2554)

Event Date 10/22/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3777-45, serial# (b)(4), implanted: (b)(6) 2009, product type: lead.Product id: 3777-45, serial# (b)(4), implanted: (b)(6) 2009, product type: lead.

Event Description

Information was received from a consumer via a manufacturer representative regarding a patient who was implanted with a neurostimulator for spinal pain.It was reported that the patient experienced intermittent stimulation and shocking starting 6 months ago, though it had intensified over the last 2 months.The manufacturer representative stated that this did not appear to be related to postural change.It was noted that the recharge interval has increased as well.An impedance check found that the lead impedances were >10,000 ohms, though the patient still felt stimulation while checking.The patient was referred to a neurosurgeon for evaluation for a lead revision/replacement.It was noted that the surgical intervention was planned, though not yet scheduled.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.Supplemental to update codes, conclusion code no longer applies.

Manufacturer Narrative

Concomitant medical products: product id neu_tlock_anchor, product type: accessory.Product id neu_tlock_anchor, product type: accessory.Product id 3777-45, serial# (b)(4), implanted: (b)(6) 2009, product type: lead.Product id 3777-45, serial# (b)(4), implanted: (b)(6) 2009, product type: lead.The lead ((b)(4)) had all conductors broken 16.9 cm from the distal end.The lead ((b)(4)) had conductor 0 and conductors 4-6 broken 17.7 cm from the distal end.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received reporting that the replacement lead would be a surgical paddle.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.Concomitant product(s): product id: neu_tlock_anchor, lot# serial# unknown, product type: accessory.Product id: neu _tlock_anchor, lot# serial# unknown, product type:l accessory.Product id: 3777-45, serial# (b)(4), implanted: (b)(6) 2009, explanted: (b)(6) 2016, product type: lead.Product id: 3777-45, serial# (b)(4), implanted: (b)(6) 2009, explanted: (b)(6) 2016, product type: lead.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient's entire system was explanted.The coverage was no longer geographically correct.The patient needed a mri compatible system.

Manufacturer Narrative

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

Manufacturer Narrative

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

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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5664294
• MDR Text Key: 45437663
• Report Number: 3004209178-2016-09768
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/12/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 59 YR