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

Model Number 97713

Device Problem Intermittent Continuity (1121)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 10/11/2016

Event Type  malfunction  

Event Description

A patient with an implantable neurostimulator (ins) reported a change in stimulation sensation over the past few weeks.The patient described the stim coming on really strong, then fading to nothing, while other times it feels normal.The patient had seen his pain management doctor the day of the call, who suggested that the patient contact a manufacturer's representative (rep) to have his device checked.The patient denies any falls or trauma related to the event.Patient described the changes as gradual.Additional information received from the rep stated he had a scheduled appointment with the patient, and did not know of any troubleshooting procedures that had been as yet performed.Patient was implanted for failed back surgery syndrome and spinal pain.

Event Description

Additional information was received from a manufacturer's representative (rep) regarding an implantable neurostimulator (ins) for the treatment of failed back surgery and spinal pain.It was reported that the patient had an appointment on (b)(6) and met with the rep.The rep stated that the patient had normal impedances and the system was operating as expected.The rep stated that the patient believed that the issue is not the device and is related to other health issues.

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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6099626
• MDR Text Key: 59784647
• Report Number: 3004209178-2016-23888
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00643169109490
• UDI-Public: 00643169109490
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2016
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2015
• 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 Age: 54 YR