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

Model Number 97702

Device Problems Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885)

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

Event Date 04/18/2014

Event Type  malfunction  

Event Description

It was reported the patient saw the elective replacement indicator (eri).It was noted the patient saw the ¿doctor¿ icon with eri the morning of the call.It was reported the patient had only been implanted for four months and was showing empty.It was noted the patient still felt stimulation.It was reported longevity calculations showed around nine months of battery life after factoring in impedances.It was noted all impedances were normal.It was reported that the battery voltage was at 2.74v.

Manufacturer Narrative

Concomitant products: product id 97740, serial# (b)(4), product type programmer, patient; product id 977a260, 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).

Event Description

It was reported, the patient was planning a replacement.It was noted the battery depletion was normal based on longevity predictions and settings.

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: 3802514
• MDR Text Key: 18866819
• Report Number: 3004209178-2014-08796
• 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,Followup
• Report Date: 04/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/14/2014
• Initial Date FDA Received: 05/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2014
• Date Device Manufactured: 09/13/2013
• 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 Age: 00083 YR