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

Model Number 97714

Device Problems Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Battery Problem (2885); Material Integrity Problem (2978)

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

Event Date 01/03/2017

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 37761, serial#: (b)(4), product type: recharger.

Event Description

Information was received from a patient.It was reported that there was a broken connector pin on their desktop charger.The patient stated that the issue occurred about three weeks prior to the date of this report.After the connector pin broke, the patient¿s implantable neurostimulator (ins) had died.The patient stated that it was ¿stone cold dead.¿ no out of box failures were reported.The caller was redirected to the repair department and a replacement desktop charger was requested.No patient symptoms were reported.Indication for use is spinal pain.

Manufacturer Narrative

Analysis of the desktop charger ((b)(4)) found that it had a broken connector pin.All fdm, fdr, and fdc codes apply to the desktop charger ((b)(4)).

Manufacturer Narrative

(b)(4) now applies to the desktop charger (b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Event is now reportable for serious injury.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer via a manufacturer¿s representative (rep).It was reported the battery was overdischarged.The battery was in overdischarge due to the patient electing to stop charging it.The battery was replaced, and the issue was resolved.No further complications were reported.

• 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 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6315373
• MDR Text Key: 66921339
• Report Number: 3004209178-2017-02926
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2014
• 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: 55 YR