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

Model Number 97714

Device Problems Break (1069); Impedance Problem (2950)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Malaise (2359)

Event Type  Injury  

Event Description

It was reported that the patient experienced a loss of therapeutic effect.It was noted that the device had been working wonderfully prior to the change in therapy.It was noted that the patient's pain returned 4-5 days prior to report.It was noted that the pain was the same kind as what he had before he got the stimulator.It was noted that the pain was not as intense as it had been before the stimulator, however, the patient was concerned that it was coming back.It was noted that "yesterday" the patient took 4 vicodins because he "felt horrible," even though he hadn't used pain medications "for awhile." it was noted that the patient still felt stimulation and that there were no changes in how he felt it.The patient was noted to have had 5 programs with e being the best for him.The other programs were tried without any better results.Fifteen days later, it was reported that the patient had an appointment with his doctor or manufacturer's representative on (b)(6) 2014.It was further reported on 2015 (b)(6) by the patient's physician that the cause of the event was a lead fracture and" impedance." reprogramming had been done on 2014 (b)(6).There was no documentation if these changes were effective.However, on 2014 (b)(6), possible lead fractures were noted.At that time, they were unable to gain leg coverage.Impedances on electrodes 13, 14 and 15 were noted (impedance reading not given).On 2014 (b)(6), the patient underwent lead replacement as well as revision of the right upper buttock pocket site.The outcome was not provided but was requested.If the outcome is obtained, a follow up report will be sent.

Manufacturer Narrative

(b)(4).

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4633333
• MDR Text Key: 5593891
• Report Number: 3004209178-2015-05420
• 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: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2015

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: 07/28/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2015
• Initial Date FDA Received: 03/25/2015
• Date Device Manufactured: 09/11/2013
• 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: 00064 YR