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

Model Number 97712

Device Problems Failure to Deliver Energy (1211); Low Battery (2584); Battery Problem (2885); Positioning Problem (3009)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

It was initially reported that the patient had stopped feeling stimulation 3 days prior.The patient stated her stimulator wasn¿t working.The patient had not been given the ok to charge it since implant.The patient had a follow up appointment for the following day.The programmer message showed that the battery was low.The patient was in pain, on her right side and in her back.This was the pain that was being treated.It was stated that therapy had stopped because the stimulator was low/dead.It was further reported that the patient was unable to adjust stimulation.An overdischarge (od) was suspected.The patient was redirected to her physician.(b)(6) 2014 crts (b)(4) update (rep): the patient had an upcoming appointment.It was further reported that the position of the battery in the pocket was less than ideal.The top of the battery stuck out and one could ¿literally pinch the top of the battery.¿ this caused the patient to have a hard time charging.It was stated that the physician planned to revise the pocket on (b)(6) 2014.The same battery will be used and it would only be a pocket revision.It was then reported that the patient cancelled the pocket revision.As of (b)(6) 2014, no one had been able to get ahold of the patient.If additional information is presented, a follow up report will be sent.

Manufacturer Narrative

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) 2014, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.(b)(4).

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: 3733739
• MDR Text Key: 4272902
• Report Number: 3004209178-2014-05780
• 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: 04/02/2014

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: 07/28/2014
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/09/2014
• Initial Date FDA Received: 04/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/10/2014
• Date Device Manufactured: 09/11/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 00045 YR