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

Model Number 97714

Device Problems Break (1069); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2015

Event Type  Injury  

Event Description

It was reported that the manufacturer representative (rep) was in a revision case.The doctor dented the implantable neurostimulator (ins) can in 1 or 2 places by the tool he was using when removing the ins from the pocket.The rep was wondering how to check the device and did not have time to provide further information.Follow-up was performed to determine what patient was involved, what the reason for the revision was, and the outcome of the dented ins.This event will be updated if additional information is received.

Manufacturer Narrative

Concomitant products: product id neu_unknown_lead, serial # unknown, product type lead.(b)(4).

Manufacturer Narrative

Concomitant medical products: product id 977a260, serial# , product type: lead.Product id 977a260, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead.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: (b)(6) 2015, product type: lead.(b)(4).

Event Description

The manufacturer's representative (rep) additionally reported that the reason for the revision was to move the existing lead for better coverage and to add another lead.Impedance check and voltage manipulations were performed on the dented battery to make sure the device was operating correctly prior to closing during surgery.The rep.Met with the patient the following week and the implantable neurostimulator (ins) seemed to operate normally.

• 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 55421 120
• 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: 4952659
• MDR Text Key: 6197268
• Report Number: 3007566237-2015-02146
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2015
• Date Device Manufactured: 02/20/2015
• 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
• Patient Age: 56 YR