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); Device Displays Incorrect Message (2591); Battery Problem (2885)

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

Event Date 11/05/2016

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

A healthcare provider (hcp) reported via the manufacturer¿s representative (rep) the implantable neurostimulator (ins) became overdischarged due to lack of charging and compliance.A trickle charge was performed and the power onreset (por) was cleared along with reeducation on recharging which resolved the issue.Relevant medical history includes non-malignant pain.Additional information was received from the patient via manufacturer representative.It was reported that the patient¿s implantable neurostimulator (ins) had difficulty holding a charge.The patient stated that it would overdischarge, charge completely, then discharge.No environmental or external factors were reported that may have led or contributed to the issue.A trickle charge was performed on the ins but didn¿t resolve the issue.The patient had the ins battery replaced on the date of this report.No patient symptoms were reported.The patient¿s status at the time of this report is ¿alive, no injury.¿.

Manufacturer Narrative

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.

Event Description

The product was returned.

Manufacturer Narrative

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

Manufacturer Narrative

Corrected information: date of birth if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis of the implantable neurostimulator (serial number (b)(4)) found that the battery had reduced capacity due to overdischarge.If information is provided in the future, a supplemental report will be issued.

• 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: 6349533
• MDR Text Key: 68035794
• Report Number: 3004209178-2017-04386
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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: 12/21/2017

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: 04/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/21/2017
• Initial Date FDA Received: 02/22/2017
• Supplement Dates Manufacturer Received: Not provided; 03/14/2017; 03/14/2017; 12/15/2017
• Supplement Dates FDA Received: 03/23/2017; 09/06/2017; 09/06/2017; 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2015
• 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: 36 YR