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

Model Number 97714

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Battery Problem (2885)

Patient Problem Discomfort (2330)

Event Date 11/01/2013

Event Type  malfunction  

Event Description

The patient was having a problem with her ¿equipment¿ and wanted to know if it was normal.The patient had to sit with the belt on for most of the day to recharge her ins and then she only gets about 36 hours of usage ¿then it shuts off¿.The device has always been like that since implant.The belt was a poor design because the patient lives alone and the belt hook was in the back.It was uncomfortable to have a disc up against her back while charging.The patient knew that the coupling bars on the bottom show how efficiently charging is and she also knew that the ins battery icon would show full when ¿tear drops¿ come out from the top.Most of the coupling bars were black when the patient charged.The patient ¿filled it up¿.The battery was all black and none of it was flashing.The patient was not concerned because it was normal.The patient knows that sometimes equipment can break.The patient wished she could get more days out of her ins before having to charge.Additional information has been requested.

Event Description

Additional information received reported that the patient did not have concerns with the device or therapy and "only wished it would stay on longer before the battery was depleted." if additional information is received, a supplemental report will be filed.

Manufacturer Narrative

Concomitant products: product id: neu_recharger_acc, lot# serial# unknown, product type: recharger.Product id: 977a290, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.(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: 3635882
• MDR Text Key: 3988739
• Report Number: 3004209178-2014-03306
• 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,Followup
• Report Date: 01/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/07/2014
• Initial Date FDA Received: 02/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/10/2014
• Date Device Manufactured: 10/10/2013
• 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