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

Model Number 97712

Device Problems Device Displays Incorrect Message (2591); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Muscle Spasm(s) (1966); Pain (1994)

Event Date 12/09/2014

Event Type  Injury  

Event Description

It was initially reported that the patient was in a lot of pain after the implant and was hospitalized for 7 days due to the pain.The patient lived alone and they were nice enough to keep him in the hospital and give him pain medications.The patient stated he only had one lead in so far.The patient was still in a lot of pain at the time of the report.The patient reported 9 days later that because he had been hospitalized and due to the holidays he hadn¿t been trained on how to charge.The patient reviewed that the recharger only needed to be plugged into charge.The patient had been having difficulty charging since the night prior and had no coupling bars.The patient was informed that the coupling bars were efficiency bars.The patient found it frustrating as he was putting the antenna in the perfect spot and doing everything right.He had tried turning the antenna dial and did so during the report and initiated a charge but still had no coupling bars.The antenna was repositioned but this did not resolve the issue.The recharger screen showed his stimulator was turned off.The patient tried turning the stimulator on and it showed that the ¿ins is discharged¿ screen.The patient was advised to charge the stimulator as he will not be able to turn it on until it was charged.The antenna locate feature was then utilized and the patient was then able to get 8 coupling bars.It had dropped to 4 bars but the patient planned to move the antenna again.During the second report, the patient stated the pain started 3 days after the implant surgery ((b)(6) 2014) and the patient was hospitalized.He stated he was hospitalized again on the following monday.The patient stated he was hospitalized again after that and they admitted him for 4-5 days from thursday to monday.At first, the patient had full body pain; he was in a spasm (or believed it was a spasm).The third time the pain was just ¿head up¿ and it was so bad they admitted him for those 4-5 days.Additional information regarding the hospitalization and the outcome was requested from the implanting physician.If received, a follow up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id 3708360, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 3708360, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 97754, serial# (b)(4), product type: recharger; product id 97740, serial# (b)(4), product type: programmer, patient; product id 3986a60, lot# n386629, implanted: (b)(6) 2014, product type: lead; product id 3986a60, lot# n386629, implanted: (b)(6) 2014, product type: lead.(b)(4).

• 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 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: 4423561
• MDR Text Key: 5276688
• Report Number: 3004209178-2015-00789
• 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
• Report Date: 12/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2015
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/24/2014
• Date Device Manufactured: 05/23/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 00051 YR