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

Model Number 97714

Device Problems Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problem Electric Shock (2554)

Event Date 05/12/2014

Event Type  malfunction  

Manufacturer Narrative

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

A manufacturing representative (rep) reported that a patient said "the stim shocked me" on (b)(6) 2014.The shocking occurs when the patient is laying down and does not occur when they stand up.The implantable neurostimulator (ins) was indicated for failed back surgery syndrome/spinal pain.

Manufacturer Narrative

Conclusion code no longer applies.

Event Description

Additional information received from the healthcare professional (hcp) of a clinical study reported that diagnostic/troubleshooting included a physical exam and a verbal report by the patient.The results of the diagnostics and troubleshooting included the sub investigator discussed that getting shocked was a common finding when laying down.Actions and interventions included the sub investigator re-educated the patient regarded position changes.The stimulation shocking the patient had resolved.

Manufacturer Narrative

Concomitant products: product id: 977a290, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 977a290, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.

Event Description

The health care provider (hcp) additionally reported that the patient experienced lead shocks.The patient experienced stimulation shocks with position change.Intervention performed was the ins was reprogrammed on (b)(6) 2014.The etiology indicated the relationship of the event to the device or therapy was related, but not related to the implant procedure.Outcome was reported as resolved without sequelae on (b)(6) 2014.

Event Description

Additional information received from the healthcare professional (hcp) of a clinical study reported that the device diagnosis was not applicable.The clinical diagnosis was patient complained of stimulation shocks with position changes.

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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5832992
• MDR Text Key: 50733460
• Report Number: 3004209178-2016-15163
• 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,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/07/2017

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: 02/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2016
• Initial Date FDA Received: 07/29/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 02/03/2017
• Supplement Dates FDA Received: 09/23/2016; 01/18/2017; 02/07/2017; 09/24/2017
• Date Device Manufactured: 04/08/2014
• 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: 71 YR