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); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Electric Shock (2554)

Event Date 02/21/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id 97754, serial# (b)(4), product type: recharger.Product id 97740, serial# (b)(4), implanted: (b)(6) 2016, product type: programmer, patient.Product id 977c165, serial# (b)(4), implanted: (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

Information was received from a consumer through a manufacturer representative regarding a patient implanted with a neurostimulator (ins) for non-malignant pain.It was reported that the patient was complaining about stimulation not providing adequate pain relief.Reprogramming was scheduled to occur on (b)(6) 2017.Additional information was received from a friend/family member of the patient on (b)(6) 2017.It was reported that the patient's stimulator was not working for them.It was reported that the patient was on high frequency, but did not feel the stimulation.It was noted that if the patient turns the stimulation up too high, they feel burning and it shocks them.If they turn it down, it doesn't control the pain.It was reported that they had tried everything with the patient programmer and without success.A physicians listing was requested as it was noted that the patient's current physician would only offer to take the device out for the patient.No further complications are anticipated.

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: 6420712
• MDR Text Key: 70521902
• Report Number: 3004209178-2017-06009
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2017
• Date Device Manufactured: 10/31/2016
• 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: 75 YR