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

Model Number 97714

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Charging Problem (2892)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Burning Sensation (2146); Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4): analysis of the implantable neurostimulator (s/n (b)(4)) found no anomaly.

Event Description

The patient experienced difficulty charging and the ins was not holding a charge.It was later reported on (b)(6) 2014 that the patient was charging more than expected since (b)(6) 2013.The battery was not staying charged, for an example the patient charged christmas eve and the battery was dead on christmas day.The patient has felt an itchy/burning sensation at the implant site since implant of ¿(b)(6) 2013¿.The patient¿s healthcare provider (hcp) thinks she may be allergic to the ins while the surgeon thinks the device is shocking her.The patient was scheduled for a battery replacement surgery on the (b)(6).It was noted that the trial went great and the patient¿s symptom relief can vary with the weather.Additional information has been requested.

Manufacturer Narrative

Concomitant products: 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.Product id: 97754, serial# (b)(4), product type: recharger.Product id: 97740, serial# (b)(4), product type: programmer, patient.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

It was later reported on (b)(6) 2014 that the burning sensation was at the right side of implant.Impedance testing was done.The battery was not holding a charge.The ins was replaced.The patient status was noted as alive, no injury.

• 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: 3692713
• MDR Text Key: 11614631
• Report Number: 3004209178-2014-04802
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2014
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2013
• 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: 00033 YR