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

Model Number 97714

Device Problem Overheating of Device (1437)

Patient Problems Purulent Discharge (1812); Pocket Erosion (2013); Tingling (2171)

Event Type  Injury  

Event Description

It was reported that the patient had bruising at the pocket site as well as tingling/burning at the pocket when he charged.The patient received excellent coverage but felt like the stimulator was heating up and gave off a ¿tens¿ like feeling.Impedances were tested and xrays were done.The patient¿s status was alive with no injury.It was further reported that the patient¿s device was explanted.A possible allergy was reported.The pocket appeared like it was trying to ¿spit it out.¿ upon opening the pocket, pus was found.It was cleaned out and the entire system was removed.Of note, the patient admitted after removal that he was allergic to a titanium wedding ring and needed a previous screw removed for ankle/knee due to rejection.An allergist was advised.If additional information is reported a follow up report will be sent.

Event Description

It was further reported that the patient was doing well.He was awaiting an appointment with an allergist to determine if there was an allergy to any components in the stimulator.No additional information was available.

Manufacturer Narrative

Product id 97754, serial# (b)(4); product type recharger product id 97740, serial# (b)(4); product type programmer, patient product id 977a260, serial# (b)(4), implanted: 2013 (b)(6); product type lead product id 977a260, serial# (b)(4), implanted: 2013 b)(6); product type lead.(b)(4).

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: 3917245
• MDR Text Key: 4513627
• Report Number: 3004209178-2014-12607
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2014
• Date Device Manufactured: 07/22/2013
• 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