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); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Battery Problem (2885); Connection Problem (2900); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Swelling (2091); Therapeutic Effects, Unexpected (2099); Discomfort (2330); Complaint, Ill-Defined (2331); Numbness (2415); Ambulation Difficulties (2544)

Event Date 04/11/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: product id: neu_ptm_prog, product type: programmer, patient.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 friend/family member of a patient with an implantable neurostimulator (ins).It was reported that the patient has had pain in the target area and discomfort and swelling at the ins site since the medications wore off after implant on (b)(6) 2017.The patient had been crying in pain and was in more pain than they were at baseline by (b)(6) 2017.The patient was feeling pain in their lower back, neck, and leg and they are also feeling heaviness and numbness in the leg.On (b)(6) 2017, the patient tried to turn on their ins and it wouldn¿t turn on.The caller reported that the ¿machine did not work.¿ it was reported that nothing showed up on the patient programmer.The patient also couldn¿t feel stimulation.The patient had a meeting with their manufacturer representative on (b)(6) 2017.No further complications are anticipated.

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 37761, serial# (b)(4), product type: recharger.(b)(4).

Event Description

Additional information received from the manufacture representative reported that the reason the patient's ins was not working was that it was in over-discharge.The patient's desktop charger connector arrows did not align with those of the ins recharger, and as a result the patient was unable to charge since implant which caused the over-discharge.The rep performed a physician mode reset (pmr) and was able to get the ins charging normally.A new desktop charge was sent to the patient.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

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 MN 00777 1200
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6547531
• MDR Text Key: 74647977
• Report Number: 3007566237-2017-01746
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• 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,Followup,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2017
• Date Device Manufactured: 12/01/2016
• 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: 66 YR