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

Model Number 97714

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Discomfort (2330); Electric Shock (2554)

Event Date 09/13/2016

Event Type  Injury  

Event Description

Information was received via a manufacturer representative from a patient who was implanted with a neurostimulator for non-malignant pain.It was reported that the patient was getting uncomfortable stimulation and shocks even with adaptivestim engaged.The cause of the uncomfortable stimulation and shocking was not determined.Adaptivestim was initiated shortly after implant as a method for troubleshooting; however it did not resolve the issue.The system was explanted on (b)(6) 2016 and was not replaced.The patient recovered without sequela.

Manufacturer Narrative

Analysis of the ins ((b)(4)) found no significant anomalies.The ins had functionally insignificant anomalies.

Manufacturer Narrative

Corrected information: sex, date of birth, no eval explain code.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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6003883
• MDR Text Key: 56591560
• Report Number: 3004209178-2016-20564
• 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
• Report Date: 01/09/2017

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: 07/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2016
• Initial Date FDA Received: 10/06/2016
• Supplement Dates Manufacturer Received: Not provided; 12/29/2016
• Supplement Dates FDA Received: 01/09/2017; 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2015
• 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: 36 YR