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

Model Number 97702

Device Problems High impedance (1291); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that the patient¿s device was replaced on (b)(6) 2015.On (b)(6) 2015, the patient presented for a post-operative programming appointment, and the early replacement indicator (eri) was displayed.It was discovered that electrode #1 (later stated to be #2) had a short and was less than 50 ohms.The device had been programmed using this electrode and it wasn¿t discovered until the day of the report there was a short.No falls or trauma occurred.The patient was not receiving therapy.The battery was replaced on (b)(6) 2015.No malfunctions were noticed upon replacement.It was unknown if the patient had therapeutic effect as he was not scheduled to be seen until (b)(6) 2015.Additional information about the outcome was requested, if received, a follow up report will be sent.Of note, the device was to be returned.

Manufacturer Narrative

Concomitant medical products: product id 97740, serial# (b)(4), product type: programmer, patient; product id 39286-65, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.(b)(4).

Event Description

Additional information received reported that the patient was getting great relief, was receiving effective therapy, and was happy.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received from the patient reported the battery was replaced due to battery depletion and stated there was a high impedance on one of his electrodes that wore the battery down.

• 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: 4636050
• MDR Text Key: 5591663
• Report Number: 3004209178-2015-05490
• 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: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2015
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2015
• Date Device Manufactured: 05/30/2014
• 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): Required Intervention