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

Model Number 97714

Device Problems High impedance (1291); Unintended Collision (1429); Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994)

Event Date 09/21/2014

Event Type  malfunction  

Event Description

It was reported that the patient had fallen and broke her pelvis and ribs; she was subsequently hospitalized.The patient fell backward onto her bottom and her walker.The patient called her company representative as she felt the stimulation had changed and was causing pain.Impedances were performed and it revealed that electrodes 9, 10, and 15 were greater than 10,000 ohms.The patient felt stimulation at the same location but it was now also going down her right leg slightly.The patient was propped onto her left side to elevate her pelvis and also had an abdominal binder on.When the company representative turned on the stimulator, the patient had pain relief, but after a while, she reported more throbbing pain in her pelvis area, low back and ribs.The patient will follow up with her device physician after she was discharged from the hospital.Additional information from the patient and her physician regarding interventions and outcome was requested.If received a follow up report will be sent.

Manufacturer Narrative

Concomitant products: product id 748951, serial # (b)(4), implanted: (b)(6) 2005, product type extension; product id 748951, serial # (b)(4), implanted: (b)(6) 2005, product type extension; product id 7435, serial # (b)(4), implanted: (b)(4) 2005, product type programmer, patient; product id 399930, lot # j0461539v, implanted: (b)(6) 2005, product type lead; product id 37742, serial # (b)(4), implanted: (b)(6) 2007, product type programmer, patient; product id 3708260, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 97754, serial # (b)(4), product type recharger; product id 3708260, serial # (b)(4), implanted: (b)(6) 2007, product type extension.(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: 4167195
• MDR Text Key: 15807143
• Report Number: 3004209178-2014-19557
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2014
• Date Device Manufactured: 04/15/2014
• 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 Age: 00083 YR