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); Positioning Problem (3009)

Patient Problems Unspecified Infection (1930); Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 07/29/2016

Event Type  Injury  

Event Description

Information was received from a patient with an implantable neurostimulator (ins) reporting that they got an infection "at the battery pack" and they had the battery pack removed but the wires were left in.Patient says that the infection occurred 3 weeks ago and confirmed it was the beginning of (b)(6).Patient states that he had the ins taken out "about the same time, about 15 or 16 days ago and was given oral antibiotics which he's still on.It is noted that the patient would like to call his doctor and stop taking the antibiotics because the wound looks pretty healthy now.The patient states that he found that "the standard version doesn't work, i couldn't find one spot where it eased my pain and couldn't feel anything from it, so i wanted to know about the high frequency thing".The patient says that "almost right away he noticed that it wasn't helping".The patient further notes that he doesn't think that the ins should have been placed "under the scar from where his arm was amputated 30 years ago".Patient says that the doctor is going to place the next ins in another location.Indication for use is non-malignant pain.

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: 6045405
• MDR Text Key: 58017377
• Report Number: 3004209178-2016-22235
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2016
• Date Device Manufactured: 07/11/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 56 YR